Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorQlaris Bio, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- QLS-111-FDC
- Latanoprost (0.005%)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov