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

NCT06177678 | Unknown Phase 2

• 1 other identifier: KJ-TFC-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and week 4

Study Arms (2)

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.

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.

Drug: COSOPT ophthalmic solution

Interventions

TFC-003 DRUG

1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.

TFC-003

COSOPT ophthalmic solution DRUG

1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.

COSOPT ophthalmic solution

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Kukje Pharma: lead

Study Sites (1)

Kukje Pharm

Seongnam-si, South Korea

Location

Related Publications (6)

• 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.

  PMID: 12049574 RESULT

• Musch 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.

  PMID: 10201583 RESULT

• Gulkilik 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.

  PMID: 22207522 RESULT

• Kitazawa 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.

  PMID: 2806924 RESULT

• Brooks 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.

  PMID: 2194358 RESULT

• Ishii 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.

  PMID: 10664926 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Central Study Contacts

Chohee Park

CONTACT

82-31-781-9081; parkch@kukjepharm.co.kr

Jongki Hong

CONTACT

82-31-781-9082; jkhong@kukjepharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: February 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

KR (1)