Clinical trial NCT01494818: Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact lenses
Contact lens solutions
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Papillae
timeFrame: Baseline, Month 3
measure: Maximum Eyelid Hyperaemia
timeFrame: Baseline, Month 3
measure: Upper Lid Redness
timeFrame: Baseline, Month 3
measure: Change From Baseline in Upper Eyelid Margin Staining at Month 3
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
timeFrame: Baseline, Month 3
measure: Protective Index
timeFrame: Baseline, Month 3
measure: Median Front Lens Deposits
timeFrame: Baseline, Month 3
measure: Total Lipid Uptake Per Lens
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
Study officials:
affiliation: OTG Research & Consultancy
name: Michel Guillon, PhD, FCOptom, FAAO, CCTI
role: PRINCIPAL_INVESTIGATOR
References: