Status:
COMPLETED
Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Lead Sponsor:
Alcon Research
Conditions:
Contact Lens Care
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 su...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01494818
Start Date
November 1 2011
End Date
July 1 2012
Last Update
September 27 2013
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