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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

NCT05456724 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TO-O-1001

TO-O-1001 ophthalmic solution in two concentration (0.05% and 0.1%) ocular administration only one drop in one eye

OTHER

Placebo

The placebo is of same visual appearance and identical formulation as TO-O-1001, except the active component TO-168 ocular administration only one drop in one eye

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Theratocular Biotek Co.

    lead INDUSTRY

Principal Investigators

  • Sam Francis · Nucleus Network Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456724 on ClinicalTrials.gov