Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses

Stopped early · Not applicable

Conditions studied: Keratoconus

In brief

The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.

Key facts

Study ID

NCT01416272

Run by

Bausch & Lomb Incorporated

People needed

12

Starts

2011-04-01

Expected to finish

2013-02-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have participated and completed a previous study (ROC2-10-078).
• Is Keratoconic

You may not qualify if…

• 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.

Where it is running

• Bausch & Lomb Incorporated — Rochester, New York, United States

Full record on ClinicalTrials.gov

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