Primary Open Angle GlaucomaPhase 2NCT06177678
A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
A Phase 2 study testing TFC-003 and COSOPT ophthalmic solution in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Kukje Pharma at 1 site in South Korea.
Trial summary
The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group 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
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- TFC-003 and COSOPT ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2024to Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Adult men and women over 19 years of age
- At the time of the screening visit for patients diagnosed with primary open-angle glaucoma or ocular hypertension (intraocular pressure 21 mmHg or higher), patients with a history of treatment or currently receiving treatment with 3 drugs according to the combination of domestically approved glaucoma treatment ingredients and fixed-dose combination drugs, or 2 drugs Patients whose intraocular pressure was not adequately controlled despite treatment history or current use of medications
- Those whose intraocular pressure (same eye) measured at 9 a.m.(±30min) at the randomization visit is 18 mmHg or higher and 34 mmHg or lower in one or both eyes
- For subjects with a history of intraocular pressure treatment before the randomization visit, those with a wash-out period of more than 5 times the half-life of the component with the longest half-life among the components of the treatment drug
- Those with a central corneal thickness of more than 480um and less than 600um
- Those who have heard and understood the sufficient explanation and voluntarily given written consent to participate in this clinical trial
Who cannot join
- Those with MD(mean deviation of visual field) loss of -20dB or more on visual field test
- Those who have undergone ocular laser surgery within 3 months of screening
- Those whose maximum corrected visual acuity(BCVA) is less than 0.25
- Those who have used systemic corticosteroids within 1 month of randomization
- Those who have used corticosteroids administered locally to the eye or eyelid within 2 weeks of randomization
- Those who received intraocular corticosteroids through intravitreal or sub-Tenon injection within 6 months of randomization
Show all 25Show fewer
- Patients with chronic, recurrent or severe inflammatory eye disease
- Those who have been diagnosed and treated for an eye infection or eye inflammation other than simple conjunctivitis within 3 months of the screening visit (in the case of simple conjunctivitis, within 2 months of the screening visit)
- Persons with a history of hypersensitivity to clinical investigational drugs of their components
- Those who need to wear contact lenses on visit days and when administering clinical trial drugs
- Women and men of childbearing age who plan to become pregnant or do not intend to use medically acceptable contraception during the clinical trial periode(however, women of childbearing age who have not undergone sterilization surgery may participate in the clinical trial only if they are tested for pregnancy and the results are negative. You must agree to participate and maintain effective contraception for the entire clinical trial period).
- Currently pregnant or lactating
- Those who have suffered eye trauma or surgery within 6 months of the screening visit
- Those who are confirmed to have a positive HBsAg or HCV Ab test result at the time of screening(can be used if test results are within 6 months from the time of screening)
- Any abnormality that precludes reliable IOP measurement (e.g. corneal opacity, nystagmus, congenital cataract, damage to photosensitive tissue cells, optic neve/optic center disease/ptosis, keratoconus, etc. that precludes IOP measruement)
- Those who have a positive history of HIV Ab in the past or are confirmed to have a positive HIV Ab test result at the time of screening (can be used if the test result is within 6 months of the time of screening)
- Patients with bronchial asthma or a history of reactive airway disease, including bronchospasm and severe chronic obstructive pulmonary disease
- Patients with sinus bradycardia, 2nd or 3rd degree atrioventricular block, obvious heart failure, cardiogenic shock, sinus dysfunction syndrome, sinoatrial block
- Those taking MAO inhibitors
- People taking antidepressants that affect noradrenaline transmission (e.g. tricyclic antidepressants, mianserin)
- People with untreated pheochromocytoma
- Subjects who, in the opinion of the investigator, have other ocular pathology (severe dry eyes, etc.) that makes it impossible to administer the investigational drug
- Patients with severe renal impairment (creatinine clearance<30mL/min) or hyperchloremic acidossis
- Persons who received other investigational drugs within 30 days of randomization
- Other people deemed unsuitable for participation in this clinical trial according to the medical opinion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kukje Pharm
Seongnam-si
Chohee Park, 82-31-781-9081, parkch@kukjepharm.co.kr
About this study
The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group in patients with primary open-angle glaucoma or ocular hypertension.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- TFC-003, COSOPT ophthalmic solution
- 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
1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.
COSOPT ophthalmic solutionDrug
1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TFC-003 | Experimental | Dorzolamide 20mg/Timolol 5mg/Brimonidine 2mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. Receives: Drug: TFC-003 |
| COSOPT ophthalmic solution | Active comparator | Dorzolamide 20mg/Timolol 5mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. Receives: Drug: COSOPT ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change from baseline in weekly intraocular pressure at 4 weeks
The Average change in intraocular pressure at 4 weeks compared to the baseline is defined as the weekly average change for measurements at 9a.m.(±30min), 11a.m.(±30min), and 2p.m.(±30min).
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06177678
- Sponsor's protocol ID
- KJ-TFC-007
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided.
Publications
Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
PubMed 12049574Musch DC, Lichter PR, Guire KE, Standardi CL. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999 Apr;106(4):653-62. doi: 10.1016/s0161-6420(99)90147-1.
PubMed 10201583Gulkilik G, Oba E, Odabasi M. Comparison of fixed combinations of dorzolamide/timolol and brimonidine/timolol in patients with primary open-angle glaucoma. Int Ophthalmol. 2011 Dec;31(6):447-51. doi: 10.1007/s10792-011-9495-z. Epub 2011 Dec 30.
PubMed 22207522Kitazawa Y, Shirai H, Go FJ. The effect of Ca2(+) -antagonist on visual field in low-tension glaucoma. Graefes Arch Clin Exp Ophthalmol. 1989;227(5):408-12. doi: 10.1007/BF02172889.
PubMed 2806924Brooks DE. Glaucoma in the dog and cat. Vet Clin North Am Small Anim Pract. 1990 May;20(3):775-97. doi: 10.1016/s0195-5616(90)50062-5.
PubMed 2194358Ishii Y, Nakamura K, Tsutsumi K, Kotegawa T, Nakano S, Nakatsuka K. Drug interaction between cimetidine and timolol ophthalmic solution: effect on heart rate and intraocular pressure in healthy Japanese volunteers. J Clin Pharmacol. 2000 Feb;40(2):193-9. doi: 10.1177/00912700022008739.
PubMed 10664926
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06177678
- Acronym / sponsor ID
- KJ-TFC-007
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kukje PharmaUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 20 Dec 2023 (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.
The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group in patients with primary open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFC-003 | Experimental | Drug: TFC-003Dorzolamide 20mg/Timolol 5mg/Brimonidine 2mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. |
| COSOPT ophthalmic solution | Active comparator | Drug: COSOPT ophthalmic solutionDorzolamide 20mg/Timolol 5mg combination drug. Participants will be administered 1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult men and women over 19 years of age
- At the time of the screening visit for patients diagnosed with primary open-angle glaucoma or ocular hypertension (intraocular pressure 21 mmHg or higher), patients with a history of treatment or currently receiving treatment with 3 drugs according to the combination of domestically approved glaucoma treatment ingredients and fixed-dose combination drugs, or 2 drugs Patients whose intraocular pressure was not adequately controlled despite treatment history or current use of medications
- Those whose intraocular pressure (same eye) measured at 9 a.m.(±30min) at the randomization visit is 18 mmHg or higher and 34 mmHg or lower in one or both eyes
- For subjects with a history of intraocular pressure treatment before the randomization visit, those with a wash-out period of more than 5 times the half-life of the component with the longest half-life among the components of the treatment drug
- Those with a central corneal thickness of more than 480um and less than 600um
Key exclusion criteria (25 listed)
- Those with MD(mean deviation of visual field) loss of -20dB or more on visual field test
- Those who have undergone ocular laser surgery within 3 months of screening
- Those whose maximum corrected visual acuity(BCVA) is less than 0.25
- Those who have used systemic corticosteroids within 1 month of randomization
- Those who have used corticosteroids administered locally to the eye or eyelid within 2 weeks of randomization
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-0031 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. | Drug | TFC-003 |
| COSOPT ophthalmic solution1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks. | Drug | COSOPT ophthalmic solution |
Primary outcome
Average change from baseline in weekly intraocular pressure at 4 weeks
Time frame: Baseline and week 4
The Average change in intraocular pressure at 4 weeks compared to the baseline is defined as the weekly average change for measurements at 9a.m.(±30min), 11a.m.(±30min), and 2p.m.(±30min).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Results publication: PubMed 12049574Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
- Results publication: PubMed 10201583Musch DC, Lichter PR, Guire KE, Standardi CL. The Collaborative Initial Glaucoma Treatment Study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999 Apr;106(4):653-62. doi: 10.1016/s0161-6420(99)90147-1.
- Results publication: PubMed 22207522Gulkilik G, Oba E, Odabasi M. Comparison of fixed combinations of dorzolamide/timolol and brimonidine/timolol in patients with primary open-angle glaucoma. Int Ophthalmol. 2011 Dec;31(6):447-51. doi: 10.1007/s10792-011-9495-z. Epub 2011 Dec 30.
- Results publication: PubMed 2806924Kitazawa Y, Shirai H, Go FJ. The effect of Ca2(+) -antagonist on visual field in low-tension glaucoma. Graefes Arch Clin Exp Ophthalmol. 1989;227(5):408-12. doi: 10.1007/BF02172889.
- Results publication: PubMed 2194358Brooks DE. Glaucoma in the dog and cat. Vet Clin North Am Small Anim Pract. 1990 May;20(3):775-97. doi: 10.1016/s0195-5616(90)50062-5.
- Results publication: PubMed 10664926Ishii Y, Nakamura K, Tsutsumi K, Kotegawa T, Nakano S, Nakatsuka K. Drug interaction between cimetidine and timolol ophthalmic solution: effect on heart rate and intraocular pressure in healthy Japanese volunteers. J Clin Pharmacol. 2000 Feb;40(2):193-9. doi: 10.1177/00912700022008739.
- Individual participant dataSharing planned: Undecided. Not yet decided.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TFC-003 and COSOPT ophthalmic solution in people with Primary Open Angle Glaucoma 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 6 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chohee Park (82-31-781-9081, parkch@kukjepharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change from baseline in weekly intraocular pressure at 4 weeks (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06177678, which also lists 6 linked publications.
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 20 Dec 2023.