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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorKukje Pharma

About this trial

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

Eligibility criteria

Qualifiers

Male or female adults aged ≥19 years at the time of informed consent.

Diagnosis of primary open-angle glaucoma or ocular hypertension.

history of or current use of triple therapy, or

history of or current use of dual therapy (dorzolamide and a topical beta-blocker), or

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TFC-003
  • TFC-003-R1
  • TFC-003-R2+TFC-003-R3

Treatment groups

188 Participants
are divided into 3 treatment groups

Sponsors and collaborators