Status:
COMPLETED
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft 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 silicone hydrogel and sof...
Detailed Description
Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens sol...
Eligibility Criteria
Inclusion
- Normal eyes (other than correction for visual acuity);
- Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
- 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 :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT01912768
Start Date
December 1 2013
End Date
May 1 2014
Last Update
July 9 2015
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