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A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
comfilcon A
lotrafilcon B
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

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

Inclusion Criteria:

  • Is between 18 and 40 years of age (inclusive)
  • Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
  • Has had a self-reported visual exam in the last two years
  • Is an adapted soft CL wearer
  • Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
  • Has less than 0.75D spectacle cylinder in each eye
  • Is correctable to a visual acuity of 20/25 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter
  • Is willing to comply with the wear schedule (at least 40 hrs per week)
  • Is willing to comply with the visit schedule

Exclusion Criteria:

  • Has never worn contact lenses before
  • Currently wears rigid gas permeable contact lenses
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has a contact lens prescription outside the range of - 1.00 to -9.00D
  • Has a spectacle cylinder greater than -0.50D of cylinder in either eye
  • Has best corrected spectacle distance vision worse then 20/25 in either eye
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or severe insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars
  • Is aphakic
  • Is presbyopic
  • Has undergone corneal refractive surgery
  • Is participating in any other type of eye related clinical or research study

Sites / Locations

  • Family Eye Care Center
  • Golden Optometric Group
  • Drs. Quinn, Foster, &Associates
  • Davis EyeCare Associates
  • Kannarr Eye Care LLC
  • Complete Eye Care of Medina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

comfilcon A

lotrafilcon B

Arm Description

Daily wear soft contact lens comfilcon A

Daily wear soft contact lens lotrafilcon B

Outcomes

Primary Outcome Measures

Comfort at Insertion
Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Visual Quality
Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 2 Weeks.
Comfortable Wearing Time
Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)
Comfort
Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Dryness
Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Handling
Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Vision Satisfaction
Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Eye Whiteness/Redness
Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)
Overall Sensation of Moistness
Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Overall Sensation of Smoothness
Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Overall Comfort Satisfaction
Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Dryness Satisfaction
Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Handling Satisfaction
Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Vision Satisfaction
Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Satisfaction
Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Lens Preference, Pair 1 Comfilcon A
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)
Lens Preference, Pair 1 Lotrafilcon B
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )
Comfortable Wearing Time
Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Average Daily Wearing Time
Participants measure of average daily wear time for study lenses at 4 weeks.
Rewetting Drops
Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Comfort
Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Dryness
Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Handling
Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Vision Satisfaction
Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Eye Whiteness/Redness
Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Overall Sensation of Moistness
Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Overall Sensation of Smoothness
Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Overall Comfort Satisfaction
Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Dryness Satisfaction
Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Handling Satisfaction
Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Vision Satisfaction
Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Overall Satisfaction
Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Lens Preference
Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).
Lens Preference Comfort, Dryness, Vision and Overall.
Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Lens Preference for Handling
Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).

Secondary Outcome Measures

Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)
Centration
Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)
Corneal Coverage
Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Post Blink Movement
Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Push Up Test
Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)
Rewetting Drops
Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Centration
Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
Corneal Coverage
Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Post Blink Movement
Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Push Up Test
Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Binocular Visual Acuity logMAR
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Surface Wetting
Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Surface Deposition
Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Centration
Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)
Corneal Coverage
Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Post Blink Movement
Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Push Up Test
Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Overall Fit Acceptance
Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Likelihood of Switching From Habitual Lens to Study Lens
Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely
Likelihood to Continue Wearing the Study Lens
Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely
Participant Recommendation of a Study Lens
Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).
Participant Likelihood of Recommendation of a Study Lens
Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).

Full Information

First Posted
September 18, 2013
Last Updated
May 31, 2017
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01952665
Brief Title
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Official Title
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Detailed Description
Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A
Arm Type
Active Comparator
Arm Description
Daily wear soft contact lens comfilcon A
Arm Title
lotrafilcon B
Arm Type
Active Comparator
Arm Description
Daily wear soft contact lens lotrafilcon B
Intervention Type
Device
Intervention Name(s)
comfilcon A
Intervention 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 schedule for the second pair without a washout period.
Intervention Type
Device
Intervention Name(s)
lotrafilcon B
Intervention 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 schedule for the second pair without a washout period.
Primary Outcome Measure Information:
Title
Comfort at Insertion
Description
Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Time Frame
Dispense
Title
Visual Quality
Description
Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)
Time Frame
Dispense
Title
Average Daily Wearing Time
Description
Participants measure of average daily wear time for study lenses at 2 Weeks.
Time Frame
2 weeks
Title
Comfortable Wearing Time
Description
Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)
Time Frame
2 weeks
Title
Comfort
Description
Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Time Frame
2 weeks
Title
Dryness
Description
Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
Time Frame
2 weeks
Title
Handling
Description
Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
Time Frame
2 weeks
Title
Vision Satisfaction
Description
Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Time Frame
2 weeks
Title
Eye Whiteness/Redness
Description
Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)
Time Frame
2 weeks
Title
Overall Sensation of Moistness
Description
Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time Frame
2 weeks
Title
Overall Sensation of Smoothness
Description
Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time Frame
2 weeks
Title
Overall Comfort Satisfaction
Description
Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
2 weeks
Title
Overall Dryness Satisfaction
Description
Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
2 weeks
Title
Overall Handling Satisfaction
Description
Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
2 weeks
Title
Overall Vision Satisfaction
Description
Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
2 weeks
Title
Overall Satisfaction
Description
Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
2 weeks
Title
Lens Preference, Pair 1 Comfilcon A
Description
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)
Time Frame
2 weeks
Title
Lens Preference, Pair 1 Lotrafilcon B
Description
Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )
Time Frame
2 weeks
Title
Comfortable Wearing Time
Description
Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Time Frame
4 weeks
Title
Average Daily Wearing Time
Description
Participants measure of average daily wear time for study lenses at 4 weeks.
Time Frame
4 weeks
Title
Rewetting Drops
Description
Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Time Frame
4 weeks
Title
Comfort
Description
Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Time Frame
4 weeks
Title
Dryness
Description
Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Time Frame
4 weeks
Title
Handling
Description
Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Time Frame
4 weeks
Title
Vision Satisfaction
Description
Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Time Frame
4 weeks
Title
Eye Whiteness/Redness
Description
Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Time Frame
4 weeks
Title
Overall Sensation of Moistness
Description
Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time Frame
4 weeks
Title
Overall Sensation of Smoothness
Description
Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.
Time Frame
4 weeks
Title
Overall Comfort Satisfaction
Description
Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
4 weeks
Title
Overall Dryness Satisfaction
Description
Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
4 weeks
Title
Overall Handling Satisfaction
Description
Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
4 weeks
Title
Overall Vision Satisfaction
Description
Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
4 weeks
Title
Overall Satisfaction
Description
Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied
Time Frame
4 weeks
Title
Lens Preference
Description
Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).
Time Frame
4 weeks
Title
Lens Preference Comfort, Dryness, Vision and Overall.
Description
Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Time Frame
4 weeks
Title
Lens Preference for Handling
Description
Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Binocular Visual Acuity logMAR
Description
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time Frame
Dispense
Title
Surface Wetting
Description
Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time Frame
Dispense
Title
Surface Deposition
Description
Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)
Time Frame
Dispense
Title
Centration
Description
Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)
Time Frame
Dispense
Title
Corneal Coverage
Description
Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Time Frame
Dispense
Title
Post Blink Movement
Description
Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time Frame
Dispense
Title
Push Up Test
Description
Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time Frame
Dispense
Title
Overall Fit Acceptance
Description
Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)
Time Frame
Dispense
Title
Rewetting Drops
Description
Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Time Frame
2 weeks
Title
Binocular Visual Acuity logMAR
Description
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time Frame
2 Weeks
Title
Surface Wetting
Description
Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time Frame
2 Weeks
Title
Surface Deposition
Description
Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Time Frame
2 Weeks
Title
Centration
Description
Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
Time Frame
2 Weeks
Title
Corneal Coverage
Description
Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)
Time Frame
2 Weeks
Title
Post Blink Movement
Description
Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time Frame
2 Weeks
Title
Push Up Test
Description
Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time Frame
2 Weeks
Title
Overall Fit Acceptance
Description
Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Time Frame
2 Weeks
Title
Binocular Visual Acuity logMAR
Description
Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart
Time Frame
4 Weeks
Title
Surface Wetting
Description
Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)
Time Frame
4 Weeks
Title
Surface Deposition
Description
Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)
Time Frame
4 Weeks
Title
Centration
Description
Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)
Time Frame
4 Weeks
Title
Corneal Coverage
Description
Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Time Frame
4 Weeks
Title
Post Blink Movement
Description
Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time Frame
4 Weeks
Title
Push Up Test
Description
Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)
Time Frame
4 Weeks
Title
Overall Fit Acceptance
Description
Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Time Frame
4 Weeks
Title
Likelihood of Switching From Habitual Lens to Study Lens
Description
Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely
Time Frame
4 weeks
Title
Likelihood to Continue Wearing the Study Lens
Description
Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely
Time Frame
4 weeks
Title
Participant Recommendation of a Study Lens
Description
Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).
Time Frame
4 weeks
Title
Participant Likelihood of Recommendation of a Study Lens
Description
Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.
Description
The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)
Time Frame
Dispense

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) Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study Has had a self-reported visual exam in the last two years Is an adapted soft CL wearer Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive) Has less than 0.75D spectacle cylinder in each eye Is correctable to a visual acuity of 20/25 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter Is willing to comply with the wear schedule (at least 40 hrs per week) Is willing to comply with the visit schedule Exclusion Criteria: Has never worn contact lenses before Currently wears rigid gas permeable contact lenses Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a contact lens prescription outside the range of - 1.00 to -9.00D Has a spectacle cylinder greater than -0.50D of cylinder in either eye Has best corrected spectacle distance vision worse then 20/25 in either eye Has any systemic disease affecting ocular health Is using any systemic or topical medications that will affect ocular health Has any ocular pathology or severe insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars Is aphakic Is presbyopic 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
Donald Siegel, OD
Organizational Affiliation
CooperVision, US
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Eye Care Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Drs. Quinn, Foster, &Associates
City
Athens
State/Province
Georgia
ZIP/Postal Code
45701
Country
United States
Facility Name
Davis EyeCare Associates
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Kannarr Eye Care LLC
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Complete Eye Care of Medina
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55340
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

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