A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

Study Overview
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Brief Summary
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This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.

Official Title
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A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

Conditions
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Corneal Staining

Intervention / Treatment
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* Other: Multipurpose Solution #1
* Other: Multipurpose Solution #2
* Other: Mutlipurpose Solution #3
* Other: Multipurpose Solution #4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent and HIPAA document read, signed, and dated. Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses. Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study. Exclusion Criteria: History of hypersensitivity Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye One functional eye or a monofit eye Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period Abnormal lenticular opacity in the visual axis of the lens in either eye Use of concomitant topical Rx or over-the-counter (OTC) ocular medications History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multipurpose Solution #1<br>B&L Renu Fresh Multipurpose Solution | Other: Multipurpose Solution #1<br>* B&L Renu Fresh Multipurpose Solution<br>Other: Multipurpose Solution #2<br>* Optifree Replenish Multipurpose Solution<br>Other: Mutlipurpose Solution #3<br>* Ciba ClearCare Multipurpose Solution<br>Other: Multipurpose Solution #4<br>* Saline Solution<br>|
| Experimental: Multipurpose Solution #2<br>OptiFree Replenish Multipurpose Solution | Other: Multipurpose Solution #1<br>* B&L Renu Fresh Multipurpose Solution<br>Other: Multipurpose Solution #2<br>* Optifree Replenish Multipurpose Solution<br>Other: Mutlipurpose Solution #3<br>* Ciba ClearCare Multipurpose Solution<br>Other: Multipurpose Solution #4<br>* Saline Solution<br>|
| Experimental: Multipurpose Solution #3<br>Ciba ClearCare Multipurpose Solution | Other: Multipurpose Solution #1<br>* B&L Renu Fresh Multipurpose Solution<br>Other: Multipurpose Solution #2<br>* Optifree Replenish Multipurpose Solution<br>Other: Mutlipurpose Solution #3<br>* Ciba ClearCare Multipurpose Solution<br>Other: Multipurpose Solution #4<br>* Saline Solution<br>|
| Active Comparator: Multipurpose Solution #4<br>Saline Solution | Other: Multipurpose Solution #1<br>* B&L Renu Fresh Multipurpose Solution<br>Other: Multipurpose Solution #2<br>* Optifree Replenish Multipurpose Solution<br>Other: Mutlipurpose Solution #3<br>* Ciba ClearCare Multipurpose Solution<br>Other: Multipurpose Solution #4<br>* Saline Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining Severity | Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit. | Baseline, 2 Hour Period, 4 Hour Period | 
| Corneal Staining Area | Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit. | Baseline, 2 Hour Period, 4 Hour Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort | Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort) | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours | 
| Subjective Dryness | Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist) | Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corneal staining