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Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

comfilcon A

lotrafilcon B

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft toric contact lens wearer
Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

Has a contact lens prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Sites / Locations

Optometry Research Group (GIO) - Optics Department, University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

comfilcon A

lotrafilcon B

Arm Description

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Outcomes

Primary Outcome Measures

Daily and Comfortable Wearing Time

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Vision Quality Insertion, During Day, End Day

Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Vision Stability Insertion, During Day, End Day

Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Overall Sensation of Moistness

Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Overall Sensation of Smoothness

Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Comfort Satisfaction

Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Dryness Satisfaction

Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Handling Satisfaction

Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Lens Fit Satisfaction

Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Vision Satisfaction

Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Overall Satisfaction

Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Comfort Upon Contact Lens Insertion

Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)

Vision Satisfaction Upon Contact Lens Insertion

Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)

Vision Quality With Contact Lens Prescription

Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Vision Stability Upon Contact Lens Insertion

Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Visual Acuity logMAR

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).

Centration

Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)

Corneal Coverage

Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Post Blink Movement

Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Lens Orientation Primary Gaze

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)

Lens Marking Visibility

Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Lens Stability on Blink

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Lens Stability 5-10 Min

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)

Lens Overall Stability

Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)

Rotational Recovery 30/45 Deg

Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

Overall Fit Acceptance

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Daily and Comfortable Wearing Time

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Daily and Comfortable Wearing Time

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Participants Use of Rewetting Drops

Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)

Participants Use of Rewetting Drops

Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)

Vision Quality Insertion, During Day, End Day, Night

Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Vision Quality Insertion, During Day, End Day, Night

Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Vision Stability on Insertion, During Day, End Day

Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Vision Stability on Insertion, During Day, End Day

Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)

Overall Sensation of Moistness

Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Overall Sensation of Moistness

Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Overall Sensation of Smoothness

Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Overall Sensation of Smoothness

Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Comfort Satisfaction

Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Comfort Satisfaction

Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Dryness Satisfaction

Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Dryness Satisfaction

Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Handling Satisfaction

Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Handling Satisfaction

Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Vision Satisfaction

Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Vision Satisfaction

Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Lens Fit Satisfaction

Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Lens Fit Satisfaction

Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Overall Satisfaction

Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Overall Satisfaction

Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Wavefront Aberrations Root Mean Square (RMS) (3mm)

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Wavefront Aberrations RMS (3mm)

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Wavefront Aberrations RMS (5mm)

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Wavefront Aberrations RMS (5mm)

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Visual Acuity logMAR

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Visual Acuity logMAR

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)

Lens Orientation Primary Gaze

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Lens Orientation Primary Gaze

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Rotational Recovery 30/45 Deg

Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)

Rotational Recovery 30/45 Deg

Lens Surface Deposits

Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Lens Surface Deposits

Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Centration

Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Centration

Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Corneal Coverage

Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Corneal Coverage

Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)

Post Blink Movement

Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Post Blink Movement

Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Lens Marking Visibility

Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Lens Marking Visibility

Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Lens Stability on Blink

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Lens Stability on Blink

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Lens Stability 5-10 Min

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Lens Stability 5-10 Min

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Overall Stability

Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.

Overall Stability

Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.

Overall Fit Acceptance

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Overall Fit Acceptance

Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)

Secondary Outcome Measures

Limbal Hyperaemia

Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Limbal Hyperaemia

Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Limbal Hyperaemia

Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Bulbar Hyperaemia

Lower Palpebral Hyperaemia

Corneal Stromal Haze

Corneal Neovascularization

Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)

Corneal Neovascularization

Corneal Infiltrates

Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)

Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)

Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)

Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)

Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)

Participants Likelihood of Switching From Habitual Lenses to the Study Lenses

Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Participants Likelihood of Continuing to Wear the Study Lenses.

Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Participant Recommendation of a Study Lens to Friends, Family or Colleagues

Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)

Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.

Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)

Participant Preference for Their Habitual Lenses or Either of the Study Lenses

Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)

Participant Preference for Either of the Study Lenses

Full Information

NCT ID

NCT01965288

First Posted

October 11, 2013

Last Updated

July 19, 2020

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01965288

Brief Title

Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

Official Title

A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Detailed Description

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

comfilcon A

Arm Type

Experimental

Arm Description

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Arm Title

lotrafilcon B

Arm Type

Active Comparator

Arm Description

Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Intervention Type

Device

Intervention Name(s)

comfilcon A

Other Intervention Name(s)

Biofinity Toric

Intervention Description

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Intervention Type

Device

Intervention Name(s)

lotrafilcon B

Other Intervention Name(s)

Air Optix

Intervention Description

test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Primary Outcome Measure Information:

Title

Daily and Comfortable Wearing Time

Description

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)

Time Frame

Baseline

Title

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Description

Time Frame

Baseline

Title

Vision Quality Insertion, During Day, End Day

Description

Time Frame

Baseline

Title

Vision Stability Insertion, During Day, End Day

Description

Time Frame

Baseline

Title

Overall Sensation of Moistness

Description

Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Time Frame

Baseline

Title

Overall Sensation of Smoothness

Description

Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)

Time Frame

Baseline

Title

Comfort Satisfaction

Description

Time Frame

Baseline

Title

Dryness Satisfaction

Description

Time Frame

Baseline

Title

Handling Satisfaction

Description

Time Frame

Baseline

Title

Lens Fit Satisfaction

Description

Time Frame

Baseline

Title

Vision Satisfaction

Description

Time Frame

Baseline

Title

Overall Satisfaction

Description

Time Frame

Baseline

Title

Comfort Upon Contact Lens Insertion

Description

Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)

Time Frame

Dispense

Title

Vision Satisfaction Upon Contact Lens Insertion

Description

Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)

Time Frame

Dispense

Title

Vision Quality With Contact Lens Prescription

Description

Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Time Frame

Dispense

Title

Vision Stability Upon Contact Lens Insertion

Description

Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)

Time Frame

Dispense

Title

Visual Acuity logMAR

Description

Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).

Time Frame

Dispense

Title

Centration

Description

Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)

Time Frame

Dispense

Title

Corneal Coverage

Description

Time Frame

Dispense

Title

Post Blink Movement

Description

Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Time Frame

Dispense

Title

Lens Orientation Primary Gaze

Description

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)

Time Frame

Dispense

Title

Lens Marking Visibility

Description

Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Time Frame

Dispense

Title

Lens Stability on Blink

Description

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Time Frame

Dispense

Title

Lens Stability 5-10 Min

Description

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)

Time Frame

Dispense

Title

Lens Overall Stability

Description

Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)

Time Frame

Dispense

Title

Rotational Recovery 30/45 Deg

Description

Time Frame

Dispense

Title

Overall Fit Acceptance

Description

Time Frame

Dispense

Title

Daily and Comfortable Wearing Time

Description

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Time Frame

2 weeks

Title

Daily and Comfortable Wearing Time

Description

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)

Time Frame

4 weeks

Title

Participants Use of Rewetting Drops

Description

Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)

Time Frame

2 Weeks

Title

Participants Use of Rewetting Drops

Description

Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)

Time Frame

4 Weeks

Title

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Description

Time Frame

2 weeks

Title

Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction

Description

Time Frame

4 weeks

Title

Vision Quality Insertion, During Day, End Day, Night

Description

Time Frame

2 weeks

Title

Vision Quality Insertion, During Day, End Day, Night

Description

Time Frame

4 weeks

Title

Vision Stability on Insertion, During Day, End Day

Description

Time Frame

2 weeks

Title

Vision Stability on Insertion, During Day, End Day

Description

Time Frame

4 weeks

Title

Overall Sensation of Moistness

Description

Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Time Frame

2 weeks

Title

Overall Sensation of Moistness

Description

Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Time Frame

4 weeks

Title

Overall Sensation of Smoothness

Description

Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Time Frame

2 weeks

Title

Overall Sensation of Smoothness

Description

Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)

Time Frame

4 weeks

Title

Comfort Satisfaction

Description

Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Comfort Satisfaction

Description

Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Dryness Satisfaction

Description

Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Dryness Satisfaction

Description

Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Handling Satisfaction

Description

Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Handling Satisfaction

Description

Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Vision Satisfaction

Description

Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Vision Satisfaction

Description

Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Lens Fit Satisfaction

Description

Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Lens Fit Satisfaction

Description

Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Overall Satisfaction

Description

Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

2 weeks

Title

Overall Satisfaction

Description

Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)

Time Frame

4 weeks

Title

Wavefront Aberrations Root Mean Square (RMS) (3mm)

Description

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Time Frame

2 Weeks

Title

Wavefront Aberrations RMS (3mm)

Description

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).

Time Frame

4 Weeks

Title

Wavefront Aberrations RMS (5mm)

Description

Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Time Frame

2 Weeks

Title

Wavefront Aberrations RMS (5mm)

Description

Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).

Time Frame

4 Weeks

Title

Visual Acuity logMAR

Description

Time Frame

2 Weeks

Title

Visual Acuity logMAR

Description

Time Frame

4 Weeks

Title

Lens Orientation Primary Gaze

Description

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Time Frame

2 weeks

Title

Lens Orientation Primary Gaze

Description

Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)

Time Frame

4 weeks

Title

Rotational Recovery 30/45 Deg

Description

Time Frame

2 weeks

Title

Rotational Recovery 30/45 Deg

Description

Time Frame

4 weeks

Title

Lens Surface Deposits

Description

Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Time Frame

2 weeks

Title

Lens Surface Deposits

Description

Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)

Time Frame

4 weeks

Title

Centration

Description

Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Time Frame

2 weeks

Title

Centration

Description

Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)

Time Frame

4 weeks

Title

Corneal Coverage

Description

Time Frame

2 weeks

Title

Corneal Coverage

Description

Time Frame

4 weeks

Title

Post Blink Movement

Description

Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Time Frame

2 weeks

Title

Post Blink Movement

Description

Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)

Time Frame

4 weeks

Title

Lens Marking Visibility

Description

Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Time Frame

2 weeks

Title

Lens Marking Visibility

Description

Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)

Time Frame

4 weeks

Title

Lens Stability on Blink

Description

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Time Frame

2 weeks

Title

Lens Stability on Blink

Description

Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)

Time Frame

4 weeks

Title

Lens Stability 5-10 Min

Description

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Time Frame

2 weeks

Title

Lens Stability 5-10 Min

Description

Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.

Time Frame

4 weeks

Title

Overall Stability

Description

Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.

Time Frame

2 weeks

Title

Overall Stability

Description

Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.

Time Frame

4 weeks

Title

Overall Fit Acceptance

Description

Time Frame

2 weeks

Title

Overall Fit Acceptance

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Limbal Hyperaemia

Description

Time Frame

Baseline

Title

Limbal Hyperaemia

Description

Time Frame

2 weeks

Title

Limbal Hyperaemia

Description

Time Frame

4 weeks

Title

Bulbar Hyperaemia

Description

Time Frame

Baseline

Title

Bulbar Hyperaemia

Description

Time Frame

2 weeks

Title

Bulbar Hyperaemia

Description

Time Frame

4 weeks

Title

Lower Palpebral Hyperaemia

Description

Time Frame

Baseline

Title

Lower Palpebral Hyperaemia

Description

Time Frame

2 weeks

Title

Lower Palpebral Hyperaemia

Description

Time Frame

4 weeks

Title

Corneal Stromal Haze

Description

Time Frame

Baseline

Title

Corneal Stromal Haze

Description

Time Frame

2 weeks

Title

Corneal Stromal Haze

Description

Time Frame

4 weeks

Title

Corneal Neovascularization

Description

Time Frame

Baseline

Title

Corneal Neovascularization

Description

Time Frame

2 weeks

Title

Corneal Neovascularization

Description

Time Frame

4 weeks

Title

Corneal Infiltrates

Description

Time Frame

Baseline

Title

Corneal Infiltrates

Description

Time Frame

2 weeks

Title

Corneal Infiltrates

Description

Time Frame

4 weeks

Title

Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)

Description

Time Frame

2 weeks

Title

Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)

Description

Time Frame

2 weeks

Title

Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)

Description

Time Frame

4 weeks

Title

Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)

Description

Time Frame

4 weeks

Title

Participants Likelihood of Switching From Habitual Lenses to the Study Lenses

Description

Time Frame

4 weeks

Title

Participants Likelihood of Continuing to Wear the Study Lenses.

Description

Time Frame

4 weeks

Title

Participant Recommendation of a Study Lens to Friends, Family or Colleagues

Description

Time Frame

8 weeks

Title

Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.

Description

Time Frame

8 weeks

Title

Participant Preference for Their Habitual Lenses or Either of the Study Lenses

Description

Time Frame

8 weeks

Title

Participant Preference for Either of the Study Lenses

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between 18 and 40 years of age (inclusive) Has had a self-reported visual exam in the last two years Is an adapted soft toric contact lens wearer Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive) Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: A person will be excluded from the study if he/she: Has a contact lens prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye. Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Montés-Mico, OD MPhil PhD

Organizational Affiliation

Optometry Research Group (GIO) - Optics Department, University of Valencia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Optometry Research Group (GIO) - Optics Department, University of Valencia

City

Valencia

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

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