5
Participants
Start Date
October 31, 2011
Primary Completion Date
November 30, 2013
Study Completion Date
February 28, 2014
Interferon gamma-1b
"Participant 1: 2 drops of topical interferon gamma-1b three times daily in the study eye for a daily dose of 42 μg~Participant 2: 3 drops 3 times daily in the study eye for a daily dose of 63 μg, if the 1st participant's dose is deemed well-tolerated by the investigator at Weeks 1, 2 and 4.~Participant 3: 3 drops 4 times daily in the study eye for a daily dose of 84 μg, if the 2nd tolerates the daily dose of 63 μg at Weeks 1, 2 and 4.~Participants 4 and 5: 4 drops 4 times daily in the study eye for a daily dose of 112 μg, if the 3rd tolerates the daily dose of 84 μg at Weeks 1, 2 and 4.~If the 63, 84 or 112 μg doses are not well-tolerated, subsequent participants will be enrolled at the prior dose level (42, 63 or 84 μg). Well-tolerated is defined as no corneal irritation (e.g., punctuate epithelial keratitis), no coexisting conjunctival erythema and edema, and no signs of more serious toxicities (e.g., intraocular inflammation or lens changes)."
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
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INDUSTRY
National Eye Institute (NEI)
NIH