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Completed NCT07354516

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

Conditions: OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 64
Sponsor: Qlaris Bio, Inc.

Location: Shettle Eye Research Largo Florida

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 Criteria

Inclusion Criteria: * BCVA 1.0 logMAR or better in each eye (equivalent to 20/200) * Diagnosis of mild to moderate OAG or OHT in at least one eye * IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost Exclusion Criteria: * History of active ocular disease other than mild to moderate OAG/OHT * Prior use of any topical PGA without a clinically meaningful response * Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study * Use of other topical ocular concomitant medications 30 days prior * History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye. * Central corneal thickness in either eye \630 μm * Clinically significant systemic or psychiatric disease, chronic kidney disease, or hypertension, hypotension, or diabetes that is uncontrolled. * Participation in any investigational study within 30 days prior to Screening * Females who are pregnant, nursing, or not using birth control.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07354516). StuddyBuddy aggregates publicly available trial information.