Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

Study Overview
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Brief Summary
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The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Detailed Description
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Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency sometimes / frequently / constantly as evaluated by a questionnaire was considered significant.

Official Title
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A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye

Conditions
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Contact Lens Related Dry Eye

Intervention / Treatment
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* Device: Opti-Free RepleniSH
* Device: ReNu MultiPlus
* Device: Contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Reports late-day dryness symptoms with contact lens wear on questionnaire. Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses. Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment). Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Wears daily disposable contact lenses. Has significant symptoms related to lens fit or lens deposits. Requires concurrent ocular medication (rewetting drops allowed). Has used Restasis® in the last 3 months. Wears punctal plugs fitted in the last 30 days. Has any current systemic or ocular abnormality, infection or disease. Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids. Has a history of refractive surgery. Other protocol-defined exclusion criteria may apply.

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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No

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFR<br>Opti-Free RepleniSH contact lens care solution used for 30 days | Device: Opti-Free RepleniSH<br>* Contact lens care solution containing polyquaternium-1 (PQT)<br>Device: Contact lenses<br>* Daily wear, frequent replacement contact lenses per participant's habitual brand and power.<br>|
| Active Comparator: RNM<br>ReNu MultiPlus contact lens care solution used for 30 days | Device: ReNu MultiPlus<br>* Contact lens care solution containing polyhexamethylene biguanide (PHMB)<br>Device: Contact lenses<br>* Daily wear, frequent replacement contact lenses per participant's habitual brand and power.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Dryness |  | 2 weeks, one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal staining |  | 2 weeks, one month | 
| conjunctival staining |  | two weeks, one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens wear, multi-purpose solution, corneal staining