Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Study Overview
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Brief Summary
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The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Official Title
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Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop

Conditions
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Dry Eye

Intervention / Treatment
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* Device: Lubricating and Rewetting Drops
* Device: AMO Blink Contacts Lubricant Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. Use a lens care system on a regular basis. Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day. Willing to use drops 4 times per day. Exclusion Criteria: Participating in a conflicting study. An active ocular disease, any corneal infiltrative response, or are using any ocular medications. Any scar or neovascularization within the central 4mm of the cornea. Any grade 2 or greater finding during the slit lamp examination Using any systemic or topical medications that will affect ocular physiology or lens performance. Aphakic. Amblyopic. Allergic to any component in the study care products. Have had any corneal surgery.

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: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricating and Rewetting Drops<br>Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. | Device: Lubricating and Rewetting Drops<br>* Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.<br>|
| Active Comparator: AMO Blink Contacts Lubricant Eye Drops<br>AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week | Device: AMO Blink Contacts Lubricant Eye Drops<br>* Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. | Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities. | At 1 week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rewetting, lubricating, eye drops