A non-inferiority, randomized, investigator - masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost (YSLT) versus a reference drug (Xalatan®) in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) – The COMET Study

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Eye Diseases [C11]; GLAUCOMA, OCCULAR HYPERTENSION

• Registration Number: EUCTR2021-000147-45-GR
• Lead Sponsor: YONSUNG GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-11
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1) Written informed consent obtained from the subject or legal representative before any trial assessment.
2) Male or female, of any race and =18 years of age.
3) Diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension.
4) The IOP is between = 22 mm Hg and = 35 mm Hg in at least one eye at the time of screening (single measurement) and at baseline (average IOP measured at 09:00, 12:00 and 16:00 hours pre-treatment).
5) Without treatment for primary open-angle glaucoma or OHT with IOP-lowering drugs for at least 4 weeks (wash out period of 4 weeks) prior to baseline.
6) Best-corrected visual acuity =20 of 100 (Snellen) corresponding to logarithm of minimal angle of resolution (logMAR) score of 0.7.
7) No new systemic medication that may alter IOP (e.g., beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.) during the 30 days prior baseline. If the patient is currently treated with these medicinal products is expected to receive a stable regimen for 30 days prior to baseline that will be followed throughout the duration of the trial.
8) Subjects with controlled arterial blood pressure according to the judgment of the investigator.
9 Expected, as judged by the Investigator, that IOP will remain controlled with the IMP treatment without optic nerve damage or progression of visual field loss.
10) Able to understand the requirements of the clinical trial and to agree to participate in all trial visits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

1) History of chronic or recurrent inflammatory eye disease, ocular trauma or infections.
2) History of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema.
3) Narrow-angle/angle-closure glaucoma.
4) Corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer.
5) Clinically significant or progressive retinal disease.
6) Intraocular surgery within the 3 months before baseline.
7) Ocular laser surgery within one month before baseline.
8) Current use of topical, ocular, nonsteroidal anti-inflammatory drugs.
9) Treatment with local or systemic corticosteroids.
10) Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide).
11) History of allergic hypersensitivity or poor tolerance to any component of the eye drop solution (IMP) used in this clinical trial.
12) Current participation or not yet completed period (at least 30 days since the ending) of other investigational device or drug trial(s).
13) Pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified