Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

Study Overview
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Brief Summary
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The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

Detailed Description
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The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Official Title
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Evaluation of the Effects of Clear Care/AOSEPT Plus Hydrogen Peroxide Solution on the Eyelid Tissues - Part II: Comparative Evaluation With RENU MPS Over 3 Months of Wear

Conditions
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Contact Lens Care

Intervention / Treatment
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* Device: Hydrogen peroxide-based contact lens care system
* Device: PHMB-containing contact lens solution
* Device: Soft contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Read and understand Participant Information Sheet; Read, sign, and date Informed Consent; Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality; Using a PHMB-containing multipurpose contact lens solution; Symptomatic, as specified in protocol; Best corrected visual acuity of 6/9 or better in each eye; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any known sensitivity or intolerance to the contact lenses or len care products to be used; Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects; Ocular allergies or ocular disease which might interfere with contact lens wear; Use of any concomitant topical ocular medications during the study period; Participation in an investigational drug or device study within 30 days of entering the study; 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLEAR CARE/AOSEPT Plus<br>Hydrogen peroxide-based contact lens care system used per manufacturer's instructions | Device: Hydrogen peroxide-based contact lens care system<br> <br> * Other names: CLEAR CARE®/AOSEPT Plus;Device: Soft contact lenses<br>* Contact lenses identical to habitual prescription worn per usual replacement regimen<br>|
| Active Comparator: ReNu MultiPlus<br>PHMB-containing contact lens solution used per manufacturer's instructions | Device: PHMB-containing contact lens solution<br> <br> * Other names: ReNu® MultiPlus Multi-Purpose solution;Device: Soft contact lenses<br>* Contact lenses identical to habitual prescription worn per usual replacement regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Papillae | Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Maximum Eyelid Hyperaemia | Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Upper Lid Redness | The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Change From Baseline in Upper Eyelid Margin Staining at Month 3 | The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. | Baseline, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Protective Index | A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Median Front Lens Deposits | Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis. | Baseline, Month 3 | 
| Total Lipid Uptake Per Lens | The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface. | Baseline, Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Contact lens solutions