Glaucoma Open-Angle PrimaryPhase 3NCT07662759
[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing TFC-003, TFC-003-R1 and TFC-003-R2+TFC-003-R3 in people with Glaucoma Open-Angle Primary and Ocular Hypertension, run by Kukje Pharma at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glaucoma Open-Angle Primary, Ocular Hypertension
- What is being tested?
- TFC-003, TFC-003-R1 and TFC-003-R2+TFC-003-R3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Dec 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 1. 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).
Show all 28Show fewer
- 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 days prior to screening.
- 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. Subjects requiring contact lens use during the study period. 5. Known hypersensitivity, in the investigator's opinion, to any component of the investigational product or ophthalmic diagnostic eye drops.
- 6. Use of any investigational drug or device within 4 weeks prior to screening (subjects participating in non-interventional studies such as observational studies or PMS may be enrolled).
- 7. Pregnant or breastfeeding women. 8. Women and men of childbearing potential who are unwilling to use medically acceptable contraception or who plan pregnancy during the study period.
- Acceptable contraception methods:
- Hormonal contraceptives (oral, injectable, implantable, etc.) Intrauterine device (IUD) or intrauterine system (IUS) Surgical sterilization (e.g., vasectomy, hysterectomy, bilateral oophorectomy, bilateral salpingectomy) Sexual abstinence (only absolute abstinence is acceptable; periodic abstinence methods such as calendar, basal body temperature, ovulation methods, withdrawal, or barrier methods are not acceptable unless investigator-deemed strict abstinence is appropriate based on age, occupation, lifestyle, or sexual orientation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kukje Pharma Kukje Pharma contact
South Korea1 site, 1 recruiting
- Recruiting
Kukje Pharma
Seongnam
Kukje Pharma
About this study
Official title: A Prospective, Multicenter, Randomized, Investigator-Masked, Active-Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
[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
- Being tested
- TFC-003, TFC-003-R1, TFC-003-R2+TFC-003-R3
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFC-003Drug
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-R1Drug
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-R3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Drug: TFC-003-R2+TFC-003-R3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- Mean change from baseline in diurnal intraocular pressure (IOP) at Weeks 4, 8, and 24.
- Mean change from baseline in IOP measured at 8:30 AM (±1 hour) at Weeks 4, 8, 12, and 24.
- Mean change from baseline in IOP measured at 10:30 AM (±1 hour) at Weeks 4, 8, 12, and 24.
- Mean change from baseline in IOP measured at 4:30 PM (±1 hour) at Weeks 4, 8, 12, and 24.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start9 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Open-Angle PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kukje Pharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662759
- Sponsor's protocol ID
- KJ-TFC-005
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Investigator-Masked, Active-Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT07662759
- Acronym / sponsor ID
- KJ-TFC-005
- Conditions
- Glaucoma Open-Angle Primary, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Kukje PharmaUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TFC-003 | Experimental | Drug: TFC-003TFC-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 | Active comparator | Drug: TFC-003-R1TFC-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 | Active comparator | Drug: TFC-003-R2+TFC-003-R3TFC-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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFC-003TFC-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-R1TFC-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-R3TFC-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 |
Primary outcome
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.
Time frame: Baseline, 12 weeks
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.
1 secondary outcome
After 24 weeks of treatment with TFC-003 and TFC-003-R1, the two groups will be compared for each efficacy endpoint.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma Open-Angle Primary
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kukje Pharma Kukje Pharma contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TFC-003, TFC-003-R1 and TFC-003-R2+TFC-003-R3 in people with Glaucoma Open-Angle Primary and Ocular Hypertension, run by Kukje Pharma at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kukje Pharma Kukje Pharma (kj341010@kukjepharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.