Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients

• Status: Recruiting
• Trial end date: 2024-09-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qlaris Bio, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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