RecruitingPhase 2Phase 3NCT07354516

Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension

A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension


Sponsor

Qlaris Bio, Inc.

Enrollment

60 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free \[PF\], fixed-dose combination \[FDC\] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing QLS-111-FDC, a combination eye drop that pairs a new drug with a standard glaucoma medication (latanoprost), in people with open-angle glaucoma or elevated eye pressure (ocular hypertension). Researchers want to see if this combination lowers eye pressure more effectively. **You may be eligible if:** - You have mild to moderate open-angle glaucoma or elevated eye pressure in at least one eye - Your vision in each eye is at least 20/200 - You have an eye pressure of 19 mmHg or higher after a run-in period with latanoprost eye drops - You are willing to comply with the study schedule and treatments **You may NOT be eligible if:** - You have other significant eye diseases beyond glaucoma or high eye pressure - You have previously used a prostaglandin eye drop (like latanoprost) without a meaningful response - You have a history of angle-closure glaucoma, serious eye trauma, eye infection, inflammation, or prior eye surgery - You have an unusually thin or thick cornea - You have uncontrolled diabetes, kidney disease, high blood pressure, or low blood pressure - You are pregnant or nursing, or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTQLS-111-FDC

QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).

DRUGLatanoprost (0.005%)

PF latanoprost administered by TO application for 14 days QPM OU.


Locations(1)

Shettle Eye Research

Largo, Florida, United States

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NCT07354516


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