Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Study Overview
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Brief Summary
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The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Detailed Description
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The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Official Title
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Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Conditions
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Ametropia

Intervention / Treatment
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* Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
* Drug: Alcon Opti-Free® RepleniSH®
* Drug: B&L ReNu MultiPlus™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer. Has read, understood and signed an information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction. Has clear corneas and no active ocular disease. Has had an ocular examination in the last two years. Is a current soft lens wearer, replacing their lenses every two weeks to one month. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens. Has astigmatism less than or equal to -1.00 DC. Exclusion Criteria: Has any signs or symptoms of dry eye. Has any clinically significant blepharitis. Has undergone corneal refractive surgery. Is aphakic. Has any active ocular disease. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that may affect ocular health. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. Is pregnant or lactating. Is participating in any other type of clinical or research study. Currently wears daily disposable lenses. Currently wears lenses on an extended wear basis.

Ages Eligible for Study
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Minimum Age: 17 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase1 - Arm 1<br> | Drug: Alcon Opti-Free® RepleniSH® with Supraclens®<br>* Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover<br>Drug: Alcon Opti-Free® RepleniSH®<br>* Marketed Multipurpose Disinfecting Care System<br>|
| Active Comparator: Phase1 - Arm 2<br> | Drug: Alcon Opti-Free® RepleniSH® with Supraclens®<br>* Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover<br>Drug: Alcon Opti-Free® RepleniSH®<br>* Marketed Multipurpose Disinfecting Care System<br>|
| Active Comparator: Phase 2 - Arm 1<br> | Drug: Alcon Opti-Free® RepleniSH® with Supraclens®<br>* Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover<br>Drug: B&L ReNu MultiPlus™<br>* Marketed Multipurpose Disinfecting Care Systems<br>|
| Active Comparator: Phase 2 - Arm 2<br> | Drug: Alcon Opti-Free® RepleniSH® with Supraclens®<br>* Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover<br>Drug: B&L ReNu MultiPlus™<br>* Marketed Multipurpose Disinfecting Care Systems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'. | 4 weeks | 
| Lens Wettability | Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced). | 4 weeks | 
| Lens Deposits | Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dryness | Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'. | 4 weeks | 
| Subjective Vision | Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'. | 4 weeks | 
| Corneal Staining | Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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comfort, wetability, protein deposit, lipid deposit