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

Kukje Pharma1 site in 1 country60 target enrollmentFebruary 2024

ConditionsPrimary Open Angle Glaucoma Ocular Hypertension

InterventionsTFC-003 COSOPT ophthalmic solution

DrugsTFC-003 COSOPT ophthalmic solution

Overview

Phase: Phase 2
Intervention: TFC-003
Conditions: Primary Open Angle Glaucoma
Sponsor: Kukje Pharma
Enrollment: 60
Locations: 1
Primary Endpoint: Average change from baseline in weekly intraocular pressure at 4 weeks
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2024

End Date

September 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kukje Pharma

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

TFC-003

Dorzolamide 20mg/Timolol 5mg/Brimonidine 2mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.

Intervention: TFC-003

COSOPT ophthalmic solution

Dorzolamide 20mg/Timolol 5mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.

Intervention: COSOPT ophthalmic solution

Outcomes

Primary Outcomes

Average change from baseline in weekly intraocular pressure at 4 weeks

Time Frame: Baseline and week 4

The Average change in intraocular pressure at 4 weeks compared to the baseline is defined as the weekly average change for measurements at 9a.m.(±30min), 11a.m.(±30min), and 2p.m.(±30min).