drugset / Trial / NCT05456724

A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT05456724 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase I/II stage to investigate the safety, tolerability, and ocular hypotensive efficacy of TO-O-1001 in healthy volunteers and patients with Open-Angle Glaucoma or Ocular Hypertension. The proposed trial consists of 3 study parts to be conducted at Nucleus Network Melbourne. This study will enroll up to 34 evaluable healthy volunteers in part 1(SAD) and part 2(MD) and 16 evaluable patients with Open-Angle Glaucoma or Ocular Hypertension in part 3(MD). Note- As of 14Mar2023, enrolment has been completed for Part 1 and Part 2 and recruitment is pending now for Part 3.

Timeline

Start
2022-08-04
Primary completion
2023-12-31
Completion
2024-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TO-O-1001 Unknown 0.05 % Topical
Subject TO-O-1001 Unknown 0.1 % Topical