Status:
TERMINATED
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Keratoconus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
Eligibility Criteria
Inclusion
- Have participated and completed a previous study (ROC2-10-078).
- Is Keratoconic
Exclusion
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Is not correctable to 20/50 or better in each eye with contact lenses.
- Has greater than Grade 2 slit lamp exam findings.
- Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
- Has any neovascularization within the central 4mm of the cornea.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01416272
Start Date
April 1 2011
End Date
February 1 2013
Last Update
November 25 2014
Active Locations (1)
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1
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609