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A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

NCT06177678•Kukje Pharma

View on ClinicalTrials.gov

Summary

The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group in patients with primary open-angle glaucoma or ocular hypertension.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult men and women over 19 years of age
•At the time of the screening visit for patients diagnosed with primary open-angle glaucoma or ocular hypertension (intraocular pressure 21 mmHg or higher), patients with a history of treatment or currently receiving treatment with 3 drugs according to the combination of domestically approved glaucoma treatment ingredients and fixed-dose combination drugs, or 2 drugs Patients whose intraocular pressure was not adequately controlled despite treatment history or current use of medications
•Those whose intraocular pressure (same eye) measured at 9 a.m.(±30min) at the randomization visit is 18 mmHg or higher and 34 mmHg or lower in one or both eyes
•For subjects with a history of intraocular pressure treatment before the randomization visit, those with a wash-out period of more than 5 times the half-life of the component with the longest half-life among the components of the treatment drug
•Those with a central corneal thickness of more than 480um and less than 600um
•Those who have heard and understood the sufficient explanation and voluntarily given written consent to participate in this clinical trial

Exclusion Criteria

•Those with MD(mean deviation of visual field) loss of -20dB or more on visual field test
•Those who have undergone ocular laser surgery within 3 months of screening
•Those whose maximum corrected visual acuity(BCVA) is less than 0.25
•Those who have used systemic corticosteroids within 1 month of randomization
•Those who have used corticosteroids administered locally to the eye or eyelid within 2 weeks of randomization
•Those who received intraocular corticosteroids through intravitreal or sub-Tenon injection within 6 months of randomization
•Patients with chronic, recurrent or severe inflammatory eye disease
•Those who have been diagnosed and treated for an eye infection or eye inflammation other than simple conjunctivitis within 3 months of the screening visit (in the case of simple conjunctivitis, within 2 months of the screening visit)
•Persons with a history of hypersensitivity to clinical investigational drugs of their components
•Those who need to wear contact lenses on visit days and when administering clinical trial drugs
+15 more criteria

Locations (1)

Kukje Pharm

Seongnam-si, South Korea

Key Dates

Start Date

February 1, 2024

Primary Completion Date

September 1, 2024

Completion Date

September 1, 2024

Last Updated

December 20, 2023

Enrollment

ESTIMATED participants

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Interventions

TFC-003

DRUG

COSOPT ophthalmic solution

DRUG

Contacts

Chohee Park

CONTACT

82-31-781-9081 parkch@kukjepharm.co.kr

Jongki Hong

CONTACT

82-31-781-9082 jkhong@kukjepharm.co.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

Inclusion Criteria

Exclusion Criteria

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