[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

NCT07662759 | Recruiting Phase 3 DMC

• 1 other identifier: KJ-TFC-005
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

\[KJ-TFC-005\] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions

Glaucoma Open-Angle Primary; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Comparison between the two groups in the mean change in diurnal intraocular pressure from baseline to Week 12 after 12 weeks of treatment with TFC-003 and TFC-003-R1.

  All IOP measurements will be performed using the same Goldmann applanation tonometer. The study eye will be selected at baseline, and only IOP measurements from the selected study eye will be used for the efficacy analysis.

  Baseline, 12 weeks

Secondary Outcomes (1)

• After 24 weeks of treatment with TFC-003 and TFC-003-R1, the two groups will be compared for each efficacy endpoint.

  Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Study Arms (3)

TFC-003

EXPERIMENTAL

TFC-003 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).

Drug: TFC-003

TFC-003-R1

ACTIVE COMPARATOR

TFC-003-R1 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).

Drug: TFC-003-R1

TFC-003-R2+TFC-003-R3

ACTIVE COMPARATOR

TFC-003-R2 and TFC-003-R3 will be administered as one drop each into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour) every day. The two eye drops (TFC-003-R2 and TFC-003-R3) will be administered at least 10 minutes apart.

Drug: TFC-003-R2+TFC-003-R3

Interventions

TFC-003 DRUG

TFC-003 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).

TFC-003

TFC-003-R1 DRUG

TFC-003-R1 will be administered as one drop into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour).

TFC-003-R1

TFC-003-R2+TFC-003-R3 DRUG

TFC-003-R2 and TFC-003-R3 will be administered as one drop each into the affected eye(s) twice daily at approximately 8:30 AM and 8:30 PM (±1 hour) every day. The two eye drops (TFC-003-R2 and TFC-003-R3) will be administered at least 10 minutes apart.

TFC-003-R2+TFC-003-R3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults aged ≥19 years at the time of informed consent.
• Diagnosis of primary open-angle glaucoma or ocular hypertension.
• At the screening visit, subjects who meet any of the following:
• history of or current use of triple therapy, or
• history of or current use of dual therapy (dorzolamide and a topical beta-blocker), or
• inadequate IOP control despite current treatment, and who, in the investigator's judgment, have not achieved target IOP based on the degree of optic nerve damage and may benefit from additional IOP reduction with triple therapy.
• Completion of an appropriate washout period for prior glaucoma medications before the randomization visit (based on the longest washout period among the components of prior medications):
• \- Parasympathomimetics, oral or topical carbonic anhydrase inhibitors: 5 days
• \- α-agonists: 14 days (brimonidine: 28 days)
• β-antagonists, prostaglandin analogues: 28 days
• Rho-kinase inhibitors: 28 days
• Mean intraocular pressure (IOP) ≥21 mmHg in either eye at 8:30 AM (±1 hour) at the randomization visit (same eye as the study eye).
• Ability to understand and voluntarily sign the informed consent form.

You may not qualify if:

• \. Subjects with any of the following comorbidities or conditions:
• Central visual field defect with mean deviation (MD) ≤ -25 dB on visual field testing.
• Chronic, recurrent, or severe inflammatory ocular disease (e.g., scleritis, uveitis, or herpetic keratitis).
• Best-corrected visual acuity (BCVA) \< 0.25 (Han Chun Suk visual acuity chart) at both screening and randomization visits.
• Any condition that prevents reliable intraocular pressure (IOP) measurement.
• Other ocular pathology that, in the investigator's opinion, precludes use of the investigational product (e.g., severe dry eye).
• Conditions requiring additional topical or systemic IOP-lowering medications during the study.
• Reactive airway disease, including bronchial asthma or history thereof, bronchospasm, or severe chronic obstructive pulmonary disease.
• Sinus bradycardia, second- or third-degree atrioventricular block, overt heart failure, cardiogenic shock, sick sinus syndrome, or sinoatrial block.
• Severe renal impairment (creatinine clearance \<30 mL/min) or hyperchloremic acidosis.
• Untreated pheochromocytoma.
• Any severe disease that, in the investigator's judgment, renders the subject unsuitable for the study.
• \. History of the following conditions or procedures (including surgery):
• Ocular trauma or ocular surgery within 24 weeks prior to screening (cataract surgery performed \>8 weeks prior is not excluded).
• Ocular infection or ocular inflammation within 12 weeks prior to screening (within 8 weeks for simple conjunctivitis).

Sponsors & Collaborators

• Kukje Pharma: lead

Study Sites (1)

Kukje Pharma

Seongnam, South Korea

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Central Study Contacts

Kukje Pharma Kukje Pharma

CONTACT

kj341010@kukjepharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)