OKYO Pharma Limited announced the last patient of a planned 240-patient double-blind placebo-controlled phase 2 clinical trial of OK-101 to treat DED has completed the 12-week OK-101 dosing study. In addition, data analysis plans for the trial have now been finalized and submitted to FDA for feedback, in anticipation of database lock, subsequent data analysis, and reporting of top-line findings on OK-101. DED 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 United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition. Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. This phase 2, multi-center, randomized, double?blind, placebo-controlled study was designed to enroll approximately 240 subjects with DED who were randomly divided into 3 cohorts of 80 patients.

Participants were selected based on specific inclusion and exclusion criteria. The three cohorts included 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, respectively, were administered in both eyes twice daily for 12 weeks.

The duration of a patient?s treatment was approximately 14 weeks, including a 2-week run-in period, to exclude the placebo responders from the study, which is common for trials involving dry eye disease, followed by 12 weeks of dosing. 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).

This phase 2, multi-center, randomized, double?blind, placebo-controlled study was designed to enroll approximately 240 subjects with DED who were randomly divided into 3 cohorts of 80 patients. Participants were selected based on specific inclusion and exclusion criteria. The three cohorts included 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, respectively, were administered in both eyes twice daily for 12 weeks. The duration of a patient?s treatment was approximately 14 weeks, including a 2-week run-in period, to exclude the placebo responders from the study, which is common for trials involving dry eye disease, followed by 12 weeks of dosing. 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).