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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

Ocular Hypertension Clinical Trial

Official title:
A 3-Part, First-in-human, Double-Blind, Randomized, and Placebo-Controlled Study Assessing the Safety, Tolerability, and Efficacy of TO-O-1001 Ophthalmic Solution in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05456724
Study type Interventional
Source Metagone Biotech Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date August 4, 2022
Completion date July 31, 2024
View Details
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