OKYO Pharma said patients are being dosed in a randomise portion of a phase 2 trial for its OK-101 drug to treat dry eye disease (DED).
The ophthalmology-focused biopharmaceutical company said in a statement that patients are being dosed in the phase 2 trial following a two-week placebo run-in period, which is designed to minimise 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,” said OKY CEO Gary S. Jacob.
“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,” Jacob added.
The phase 2 trial will enrol roughly 240 patients with DED, who will be equally divided into three cohorts.
One cohort will be supplied with the placebo, while the other two will receive 0.05% OK-101 and 0.01% OK-101, administered twice daily for 12 weeks.
DED is a common condition, impacting 49mln people in the US alone, and occurs when tears are unable to adequately lubricate the eyes.