BridgeMD
Tests treatment safety and results for Glaucoma Open-Angle Primary
Official title [KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT07662759
What this study is testing
What is TFC-003?
TFC-003 is an investigational medicine, given as an once-daily, being studied as a potential treatment for glaucoma open-angle primary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- [KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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, people 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
You likely can't join if
- 1\. people 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).
See the full eligibility 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, people 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...
- 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...
- 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.
- 1\. people 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. 2\. 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).
- Ocular laser surgery within 12 weeks prior to screening. 3\. Prior or concomitant medications:
- Oral beta-blockers within 4 weeks prior to randomization.
- Addition of antihypertensive agents that may affect IOP within 4 weeks prior to randomization (excluding beta-blockers; e.g., calcium channel blockers, ACE inhibitors), unless the regimen has been stable for at least 7...
- α-adrenergic agonists, MAO inhibitors, or antidepressants affecting norepinephrine transmission within 2 weeks prior to randomization.
- Topical ocular or periocular corticosteroids within 2 weeks prior to randomization.
- Systemic corticosteroids within 4 weeks prior to randomization.
- Intravitreal or sub-Tenon corticosteroid injection within 24 weeks prior to randomization. 4\. people requiring contact lens use during the study period. 5. Known hypersensitivity, in the investigator's opinion, to any...
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.