Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

Detailed Description
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This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

Official Title
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Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Conditions
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Myopia

Intervention / Treatment
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* Device: Contact lens multi-purpose solution
* Other: Saline/blister pack solution
* Device: Contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have read, understood, signed, and dated the written Informed Consent. Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks. Vision correctable to at least 20/30 Snellen. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Topical ocular medication use. History of hypersensitivity to any component of the study contact lens care systems. Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period. Pregnant, lactating, or planning a pregnancy. 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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contact lens solution #1<br> | Device: Contact lens multi-purpose solution<br>* Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.<br>* Other names: Hydron;Device: Contact lenses<br>* CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.<br>* Other names: Biofinity;|
| Experimental: Contact lens solution #2<br> | Device: Contact lens multi-purpose solution<br>* Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.<br>* Other names: Hydron;Device: Contact lenses<br>* CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.<br>* Other names: Biofinity;|
| Experimental: Contact lens solution #3<br> | Device: Contact lens multi-purpose solution<br>* Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.<br>* Other names: Hydron;Device: Contact lenses<br>* CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.<br>* Other names: Biofinity;|
| Experimental: Contact lens solution #4<br> | Device: Contact lens multi-purpose solution<br>* Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.<br>* Other names: Hydron;Device: Contact lenses<br>* CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.<br>* Other names: Biofinity;|
| Active Comparator: Saline/blister pack solution<br> | Other: Saline/blister pack solution<br>* A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.<br>* Other names: Saline;Device: Contact lenses<br>* CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.<br>* Other names: Biofinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort |  | 2 hours | 

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