Status:
COMPLETED
Product Performance of a Daily Disposable Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
FEMALE
15-38 years
Phase:
NA
Brief Summary
The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch \& Lomb daily disposable cosmetic tint contact lens (Test) when worn on a...
Eligibility Criteria
Inclusion
- Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.
Exclusion
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects who have any systemic disease affecting ocular health.
- 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 are using any ocular medication.
- Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- Subjects who are aphakic or amblyopic.
- Subjects who have had any corneal surgery (eg, refractive surgery).
- Subjects who currently wear monovision, multifocal, or toric contact lenses.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01230554
Start Date
August 1 2010
End Date
November 1 2010
Last Update
August 28 2019
Active Locations (1)
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1
Bausch & Lomb
Singapore, Singapore, 556741