A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 63
- Locations
- 6
- Primary Endpoint
- Dryness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
lotrafilcon B
Daily wear soft contact lens lotrafilcon B
Intervention: comfilcon A (Device)
comfilcon A
Daily wear soft contact lens comfilcon A
Intervention: lotrafilcon B (Device)
Outcomes
Primary Outcomes
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).
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 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 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
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).
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)
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 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 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, 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 )
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).
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)
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)
Average Daily Wearing Time
Time Frame: 4 weeks
Participants measure of average daily wear time for study lenses at 4 weeks.
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).
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)
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).
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
Secondary Outcomes
- Corneal Coverage(4 Weeks)
- Surface Wetting(4 Weeks)
- Surface Deposition(4 Weeks)
- Binocular Visual Acuity logMAR(4 Weeks)
- Centration(4 Weeks)
- Post Blink Movement(4 Weeks)
- Push Up Test(4 Weeks)
- Likelihood to Continue Wearing the Study Lens(4 weeks)
- Participant Recommendation of a Study Lens(4 weeks)
- Rewetting Drops(2 weeks)
- Overall Fit Acceptance(4 Weeks)
- Likelihood of Switching From Habitual Lens to Study Lens(4 weeks)
- Participant Likelihood of Recommendation of a Study Lens(4 weeks)
- Binocular Visual Acuity logMAR(Dispense)
- Surface Wetting(Dispense)
- Surface Deposition(Dispense)
- Centration(Dispense)
- Corneal Coverage(Dispense)
- Post Blink Movement(Dispense)
- Push Up Test(Dispense)
- Overall Fit Acceptance(Dispense)
- Binocular Visual Acuity logMAR(2 Weeks)
- Surface Wetting(2 Weeks)
- Surface Deposition(2 Weeks)
- Centration(2 Weeks)
- Corneal Coverage(2 Weeks)
- Post Blink Movement(2 Weeks)
- Push Up Test(2 Weeks)
- Overall Fit Acceptance(2 Weeks)