Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT05138861
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.
Study:
NCT05138861
Study Brief:
Protocol Section:
NCT05138861