Status:
COMPLETED
Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
Lead Sponsor:
Qlaris Bio, Inc.
Conditions:
Primary Open Angle Glaucoma (POAG)
Primary Open Angle Glaucoma of Both Eyes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
Detailed Description
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular h...
Eligibility Criteria
Inclusion
- 18 years or older
- Able to provide written acknowledgement of giving informed consent
- Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Exclusion
- IOP \>34 mmHg
- Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- Use of other ophthalmic concomitant medications during the study
- Uncontrolled hypertension or hypotension
- Significant systemic or psychiatric disease
- Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
- Pregnant or lactating
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06016972
Start Date
March 5 2024
End Date
August 20 2024
Last Update
January 20 2025
Active Locations (1)
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1
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076