A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects
brief summary
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration.
detailed description
This is a single-center, open-label, single-arm study. A single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 1 and then twice a day (in the morning and in the evening, approximately 12 hours apart) starting on Day 2 for 40 consecutive days (Days 2 to 41). Thereafter, a single drop of the ophthalmic solution will be instilled in each eye on the morning of Day 42, for a total of 82 consecutive doses administered in each eye. The doses of Days 1, 2 (morning), 41 (evening), and 42 will be self-administered under supervision of the site staff at the clinical site. All remaining doses will be self-administered at home. Throughout the study, PK blood samples will be collected and safety assessments will be performed.
official title
Pharmacokinetic Study to Evaluate the Whole Blood Pharmacokinetics of TP-03 Following Six Week Topical Ocular Administration