Ocular Comfort and the Aging Lens (ERBIUM)

Study Overview
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Brief Summary
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The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Detailed Description
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Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Official Title
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Ocular Comfort and the Aging Lens (ERBIUM)

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Habitual contact lens
* Device: Lotrafilcon B contact lens
* Device: Contact lens cleaning and disinfecting system (ClearCare)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 17 years of age. Ocular exam in the last two years. Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule. Wearing contact lenses at least five days per week for a minimum of 10 hours each day. Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any ocular disease. Systemic condition that may affect a study outcome. Using any systemic or topical medications that may affect ocular health. Wears lenses on an extended or continuous wear schedule. Habitually wears multifocal lenses. 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 1: Habitual no Replacement, then Habitual Replacement<br>Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28. | Device: Habitual contact lens<br>* Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription<br>|
| Other: Phase 1: Habitual Replacement, then Habitual no Replacement<br>Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement. | Device: Habitual contact lens<br>* Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription<br>|
| Other: Phase 2: Lotrafilcon B Replacement<br>Contact lenses worn for 56 days with replacement pair dispensed at Day 28. | Device: Lotrafilcon B contact lens<br>* Commercially marketed silicone hydrogel contact lens<br>* Other names: AIR OPTIX AQUA;Device: Contact lens cleaning and disinfecting system (ClearCare)<br>* Commercially marketed, hydrogen peroxide-based contact lens care system<br>* Other names: CLEARCARE;|
| Other: Phase 3: Lotrafilcon B Replacement Replacement<br>Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28. | Device: Lotrafilcon B contact lens<br>* Commercially marketed silicone hydrogel contact lens<br>* Other names: AIR OPTIX AQUA;Device: Contact lens cleaning and disinfecting system (ClearCare)<br>* Commercially marketed, hydrogen peroxide-based contact lens care system<br>* Other names: CLEARCARE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 1 | 
| Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 1 | 
| Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 1 | 
| Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 15 | 
| Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 15 | 
| Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 15 | 
| Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 43 | 
| Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 43 | 
| Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day | Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (I CANNOT tolerate the comfort of my eyes! I am in pain!)and 100=VERY COMFORTABLE & FRESH (Wow! My eyes feel incredible! I love this feeling.) | Day 43 |