Status:
COMPLETED
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers
Lead Sponsor:
Alcon Research
Conditions:
Myopia
Astigmatism
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearer...
Detailed Description
Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive ei...
Eligibility Criteria
Inclusion
- Normal eyes (other than correction for visual acuity);
- Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;
- Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
- Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
- Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
- History of intolerance or hypersensitivity to any component of the investigational products;
- Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
- Moderate, severe, abnormal, or other ocular findings;
- Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
- Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
- Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
- Ocular surgery within the last 12 months;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01912781
Start Date
November 1 2013
End Date
May 1 2014
Last Update
June 30 2015
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