[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary … (NCT07662759) | Clinical Trial Compass
RecruitingPhase 3
[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
South Korea188 participantsStarted 2025-12-09
Plain-language 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
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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):
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.