Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

Study Overview
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Brief Summary
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The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.

Official Title
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Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining

Conditions
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Corneal Staining

Intervention / Treatment
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* Device: Opti-Free RepleniSH
* Device: ReNu MultiPlus
* Device: Balafilcon A
* Other: Unisol 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For non-lens wearers: Normal eyes. Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months. Free of dry eye using the Ocular Surface Disease Index (Schiffman et al). Other protocol-defined inclusion criteria may apply. For contact lens wearers: Currently wearing soft contact lenses. Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002). Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear). Reports only occasional use of contact lens rewetting drops or artificial tears. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: For non-lens wearers and contact lens wearers: Pregnant. Participating in another research study. Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by extent of staining across 5 regions). Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contact lens wearers<br>Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline. | Device: Opti-Free RepleniSH<br>* Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.<br>Device: ReNu MultiPlus<br>* Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.<br>* Other names: Renu;Device: Balafilcon A<br>* Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.<br>* Other names: PureVision;Other: Unisol 4<br>* Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.<br>|
| No Intervention: Non-lens wearers<br>Non-lens wearers completed one study visit and served as the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Protein Expression |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Contact lens solution, Corneal staining