Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension (OHT)
In brief
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.
Key facts
- Study ID
- NCT06016972
- Run by
- Qlaris Bio, Inc.
- People needed
- 63
- Starts
- 2024-03-05
- Expected to finish
- 2024-08-20
- Last updated by the study team
- 2025-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Coastal Research Associates, LLC — Roswell, Georgia, United States
Full record on ClinicalTrials.gov
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