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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 79
- Primary Endpoint
- Maximum Eyelid Hyperaemia
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Maximum Eyelid Hyperaemia
Time Frame: Baseline, Month 3
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.
Change From Baseline in Upper Eyelid Margin Staining at Month 3
Time Frame: Baseline, 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.
Maximum Papillae
Time Frame: Baseline, Month 3
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.
Upper Lid Redness
Time Frame: Baseline, Month 3
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.
Secondary Outcomes
- Protective Index(Baseline, Month 3)
- Median Front Lens Deposits(Baseline, Month 3)
- Total Lipid Uptake Per Lens(Baseline, Month 3)
- Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)(Baseline, Month 3)