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

December 11, 2023 updated by: Kukje Pharma
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TFC-003
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
1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.
Active Comparator: COSOPT ophthalmic solution
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
1 drop of TFC-003 ophthalmic solution twice a day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kukje Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KJ-TFC-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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