Efficacy and Safety of HUC3-637 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

January 11, 2026 updated by: Huons Co., Ltd.

A Multicenter, Randomized, Single-blind, Active Controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HUC3-637 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

A multicenter, randomized, single-blind, active controlled, phase III clinical trial to evaluate the efficacy and safety of HUC3-637 in patients with primary open angle glaucoma or ocular hypertension

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 19 years and older
  • Participants diagnosed with POAG or OH
  • Have fully explained and understood the study and have voluntarily given written informed consent.

Exclusion Criteria:

  • Acute or chronic angle-closure glaucoma
  • Congenital glaucoma, secondary glaucoma (open-angle glaucoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HUC3-637
Dorzolamide, Timolol
Drug: HUC3-637
Ophthalmic solution instilled directly into the eye (topical ocular administration)
Active Comparator: HUC3-637-R
Dorzolamide, Timolol
Drug: HUC3-637-R
Ophthalmic solution instilled directly into the eye (topical ocular administration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in diurnal IOP
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUC3-637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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