Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens ...
Eligibility Criteria
Inclusion
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be myopic, and wear contact lenses in each eye.
- Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
Exclusion
- Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with an active ocular disease or who are using any ocular medication.
- Subjects with any grade 2 or greater finding during the slit lamp examination.
- Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects who are allergic to any component in the study care products.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01449526
Start Date
August 1 2011
End Date
January 1 2012
Last Update
February 18 2015
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