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Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Fanfilcon A toric lens
Lotrafilcon B toric lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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 contact lens wearer
  • Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
  • Have no less than -0.75D of astigmatism and no more than -2.25 D 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 CL prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
  • Has a history of not achieving comfortable CL 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 Clinic, National Autonomous University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fanfilcon A toric

lotrafilcon B

Arm Description

Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.

Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.

Outcomes

Primary Outcome Measures

Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Lens Centration
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Corneal Coverage
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Post-blink Movement
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Overall Fit Acceptance
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)

Secondary Outcome Measures

Average Hours of Wear Per Day
Number of hours lenses are worn per day
Average Hours of Wear Per Day
Number of hours lenses are worn per day
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation.
Average Comfortable Wearing Time
Typical time of day when subject first experiences lens awareness or irritation

Full Information

First Posted
January 25, 2018
Last Updated
October 23, 2019
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03418064
Brief Title
Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
Official Title
Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.
Detailed Description
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fanfilcon A toric
Arm Type
Experimental
Arm Description
Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study.
Arm Title
lotrafilcon B
Arm Type
Active Comparator
Arm Description
Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study.
Intervention Type
Device
Intervention Name(s)
Fanfilcon A toric lens
Other Intervention Name(s)
Avaira Vitality toric lens
Intervention Description
Contact lens
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B toric lens
Other Intervention Name(s)
AIR OPTIX for Astigmatism
Intervention Description
Contact lens
Primary Outcome Measure Information:
Title
Lens Centration
Description
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time Frame
Baseline
Title
Lens Centration
Description
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time Frame
Dispense
Title
Lens Centration
Description
Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)
Time Frame
1 Month
Title
Corneal Coverage
Description
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time Frame
Baseline
Title
Corneal Coverage
Description
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time Frame
Dispense
Title
Corneal Coverage
Description
Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)
Time Frame
1 Month
Title
Post-blink Movement
Description
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time Frame
Baseline
Title
Post-blink Movement
Description
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time Frame
Dispense
Title
Post-blink Movement
Description
Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)
Time Frame
1 Month
Title
Overall Fit Acceptance
Description
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Time Frame
Dispense
Title
Overall Fit Acceptance
Description
Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Average Hours of Wear Per Day
Description
Number of hours lenses are worn per day
Time Frame
Baseline
Title
Average Hours of Wear Per Day
Description
Number of hours lenses are worn per day
Time Frame
1 month
Title
Average Comfortable Wearing Time
Description
Typical time of day when subject first experiences lens awareness or irritation.
Time Frame
Baseline
Title
Average Comfortable Wearing Time
Description
Typical time of day when subject first experiences lens awareness or irritation
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 contact lens wearer Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) Have no less than -0.75D of astigmatism and no more than -2.25 D 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 CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye. Has a history of not achieving comfortable CL 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.
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

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Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

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