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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2013

Detailed Description

Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Interventions

  • Device: comfilcon A
    • 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.
  • Device: lotrafilcon B
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: comfilcon A
    • Daily wear soft contact lens comfilcon A
  • Active Comparator: lotrafilcon B
    • Daily wear soft contact lens lotrafilcon B

Clinical Trial Outcome Measures

Primary Measures

  • Comfort at Insertion
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: 2 weeks
    • Participants measure of average daily wear time for study lenses at 2 Weeks.
  • Comfortable Wearing Time
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
  • Dryness
    • Time Frame: 2 weeks
    • Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).
  • Handling
    • Time Frame: 2 weeks
    • Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).
  • Vision Satisfaction
    • Time Frame: 2 weeks
    • Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
  • Eye Whiteness/Redness
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • Participants measure of average daily wear time for study lenses at 4 weeks.
  • Rewetting Drops
    • Time Frame: 4 weeks
    • Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
  • Comfort
    • Time Frame: 4 weeks
    • Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
  • Dryness
    • Time Frame: 4 weeks
    • Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
  • Handling
    • Time Frame: 4 weeks
    • Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
  • Vision Satisfaction
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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.
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).

Secondary Measures

  • Binocular Visual Acuity logMAR
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: Dispense
    • 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
    • Time Frame: 2 weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal
  • Corneal Coverage
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 2 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
  • Post Blink Movement
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 Weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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
    • Time Frame: 4 weeks
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Coopervision, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donald Siegel, OD, Principal Investigator, CooperVision, US

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