OKYO Pharma Announces Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease
Trial designed with a two-week run-in period to reduce the well-known placebo effect in trials involving pain component
Top-line data from trial anticipated in Q4, 2023
LONDON and NEW YORK, June 06, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease (DED) to address the significant unmet need in this multi-billion-dollar market, is pleased to announce that patients are now being dosed in the randomized portion of the phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat DED, following the two-week placebo run-in period intended to minimize the placebo effect.
“A two-week placebo run-in period involving topical ocular dosing of placebo is an innovative approach used by our clinical development partner, Ora Inc. This design feature reduces the well-known placebo effect for ocular trials such as ours that include an ocular discomfort readout,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “This run-in period enables us to evaluate potential patients for the placebo effect during the run-in screening period, improving patient selection for the randomized treatment portion of the trial. Importantly, this first clinical study is also designed to include two pre-specified primary efficacy endpoints which are the hallmark of phase 3 registration trials, and one of the efficacy endpoints deals specifically with ocular discomfort.”
Dry eye disease is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to treat due to the multifactorial nature of the condition. A number of contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface.
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