Objective Testing of Tear Film Stability

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.

Official Title
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Objective Testing of Tear Film Stability

Conditions
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Contact Lens Solutions

Intervention / Treatment
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* Device: Opti-Free® RepleniSH® MPDS
* Device: ReNu MultiPlus®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be at least 18 years of age and no more than 80 years of age. The subject must have a best corrected visual acuity of 20/30 or better for each eye. The subject must habitually wear contact lenses. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation. The subject must read understand and sign the Statement of Informed Consent. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. Exclusion Criteria: Ocular or systemic allergies or disease that might interfere with contact lens wear. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Pregnancy or lactation. Diabetes Infectious diseases (e.g. hepatitis, tuberculosis) Contagious immunosuppressive diseases (e.g. HIV)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Opti-Free® RepleniSH® MPDS | Device: Opti-Free® RepleniSH® MPDS<br>* soft contact lens disinfecting solution<br>|
| Active Comparator: 2<br>Renu MultiPlus® | Device: ReNu MultiPlus®<br>* soft contact lens disinfecting solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective, In-vivo Soft Contact Lens Wettability Index | The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Questionnaire Response | Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film