NCT07354516

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Detailed description

14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.

Conditions

• OAG - Open-Angle Glaucoma
• OHT - Ocular Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	QLS-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).
DRUG	Latanoprost (0.005%)	PF latanoprost administered by TO application for 14 days QPM OU.

Timeline

• Start date: 2026-03-18
• Primary completion: 2026-07-01
• Completion: 2026-07-15
• First posted: 2026-01-21
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study