This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a day administration for 14 days will start~Primary objectives:~Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers~Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers~Secondary objectives:~To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers~To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers~Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.