Phase 3 Glaucoma Trial, Recruiting NCT07662759 Sponsor: Kukje Pharma Condition: Glaucoma
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Phase 3 Glaucoma Trial, Recruiting

NCT07662759
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 19 years of age or older
  • You have been diagnosed with a type of glaucoma called primary open-angle glaucoma, or with higher-than-normal eye pressure (ocular hypertension)
  • You are currently using, or have previously used, a combination of three eye pressure-lowering medications, OR a combination of two specific medications (dorzolamide and a topical beta-blocker), OR your current treatment is not controlling your eye pressure well enough and your doctor feels you may benefit from a three-medication combination
  • You have stopped taking your previous glaucoma medications for a specific waiting period before the study starts (the length of time depends on which medications you were taking — confirm with trial site)
  • Your eye pressure measures 21 mmHg or higher in at least one eye at a specific morning measurement at the start of the study
  • You are able to understand and willingly sign a consent form agreeing to take part

Who may not be able to join:

  • You have a severe loss of central vision as measured by a specific eye test
  • You have a chronic, recurring, or serious inflammatory eye disease, such as severe eye inflammation or a herpes eye infection
  • Your best corrected vision (even with glasses or contacts) is below a certain level in both eyes at two separate visits
  • You have any condition that makes it impossible to accurately measure your eye pressure
  • You have another eye condition that, in the doctor's opinion, makes it unsafe to use the study medication (for example, severe dry eye)
  • You need additional eye pressure-lowering medications beyond what the study provides
  • You have asthma, a history of asthma, bronchospasm, or severe chronic lung disease
  • You have certain heart conditions, such as a very slow heart rate, specific types of heart block, heart failure, cardiogenic shock, or related conditions
  • You have severe kidney problems or a specific blood chemistry imbalance (confirm with trial site)
  • You have an untreated tumour of the adrenal gland called pheochromocytoma
  • You have any other serious illness that the investigator feels makes participation unsafe
  • You had eye injury or eye surgery within the past 24 weeks (note: cataract surgery done more than 8 weeks ago may still be acceptable — confirm with trial site)
  • You had an eye infection or eye inflammation within the past 12 weeks (or within 8 weeks for simple conjunctivitis)
  • You had laser eye surgery within the past 12 weeks
  • You took oral beta-blocker medications within the past 4 weeks
  • Certain blood pressure medications were added or changed within the past 4 weeks, unless the dose has been stable for at least 7 days before your screening visit
  • You took certain medications affecting the nervous system (such as MAO inhibitors, certain antidepressants, or alpha-adrenergic agonists) within the past 2 weeks
  • You used steroid eye drops or creams around the eye within the past 2 weeks
  • You used oral or systemic steroids within the past 4 weeks
  • You had a steroid injection into or around the eye within the past 24 weeks
  • You need to wear contact lenses during the study
  • You have a known allergy to any ingredient in the study medication or to eye drops used for diagnosis
  • You have taken part in another clinical drug or device trial within the past 4 weeks
  • You are currently pregnant or breastfeeding
  • You are a woman or man who could potentially have children and are unwilling to use an acceptable form of contraception during the study, or you plan to become pregnant during the study (acceptable methods include hormonal contraceptives, an IUD/IUS, surgical sterilisation, or complete abstinence — confirm with trial site for full details)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Kukje Pharma
Registry
ClinicalTrials.gov
Start date
9 December 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov