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

ConditionsGlaucoma Open-Angle PrimaryOcular 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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-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-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.

Treatment groups

188 Participants
are divided into 3 treatment groups
Group A: TFC-003Experimental treatment 1 intervention
Group B: TFC-003-R1Active comparator 1 intervention
Group C: TFC-003-R2+TFC-003-R3Active comparator 1 intervention

Trial outcomes

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.

Time frame
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.

1. Mean change from baseline in diurnal intraocular pressure (IOP) at Weeks 4, 8, and 24. 2. Mean change from baseline in IOP measured at 8:30 AM (±1 hour) at Weeks 4, 8, 12, and 24. 3. Mean change from baseline in IOP measured at 10:30 AM (±1 hour) at Weeks 4, 8, 12, and 24. 4. Mean change from baseline in IOP measured at 4:30 PM (±1 hour) at Weeks 4, 8, 12, and 24.

Time frame
Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kukje Pharma

Lead sponsor

Source ClinicalTrials.gov
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