Lens Wear Schedules and End-of-Day Comfort

Study Overview
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Brief Summary
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The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

Detailed Description
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This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Official Title
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Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear

Conditions
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Myopia

Intervention / Treatment
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* Device: Lotrafilcon B
* Device: Senofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer. Is willing and able to follow instructions and maintain the appointment schedule. Has had an ocular examination in the last two years. Is an adapted soft contact lens wearer. Experiences a decrease in ocular comfort through a lens-wearing day. Has a current pair of spectacles. Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses. Has astigmatism less than or equal to -1.00 DC. Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Has any ocular disease. Has a systemic condition that may affect a study outcome variable. Is using any systemic or topical medications that may affect ocular health. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon B / Senofilcon A<br>Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days). | Device: Lotrafilcon B<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.<br>* Other names: AIR OPTIX® AQUA;Device: Senofilcon A<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.<br>* Other names: ACUVUE® OASYS®;|
| Other: Senofilcon A / Lotrafilcon B<br>Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days). | Device: Lotrafilcon B<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.<br>* Other names: AIR OPTIX® AQUA;Device: Senofilcon A<br>* Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.<br>* Other names: ACUVUE® OASYS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean End-of-Day Comfort | As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. | Hour 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Non-Invasive Tear Film Break-Up Time (NITBUT) | As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience. | Hour 12 |