OKYO Pharma Limited announcef 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, PhD, 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.
About the phase 2 trial design
This phase 2, multi-center, randomized, double–blinded, placebo-controlled study is planned to enroll approximately 240 subjects with DED who will be randomly divided into 3 cohorts of 80 patients. Participants will be selected based on specific inclusion and exclusion criteria.
The three cohorts will be comprised of one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101. The drug and placebo will be administered in both eyes twice daily for 12 weeks.
The duration of a patient’s treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov public website (clinicaltrials.gov Identifier: NCT05759208 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).