Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
- Conditions
- Primary Open Angle Glaucoma of Both EyesPrimary Open Angle Glaucoma (POAG)Ocular Hypertension (OHT)Primary Open-Angle Glaucoma, Unspecified Eye
- Interventions
- Other: QLS-111 ophthalmic vehicle solution
- Registration Number
- NCT06016972
- Lead Sponsor
- Qlaris Bio, Inc.
- 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 hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QLS-111 ophthalmic vehicle solution QLS-111 ophthalmic vehicle solution Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
- Primary Outcome Measures
Name Time Method Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) 21 days Ocular safety and tolerability: adverse events (AEs)
Clinically significant change in findings on fundus exam 21 days Ocular safety and tolerability: fundus
Clinically significant changes in heart rate (HR) 21 days Systemic safety and tolerability: vital signs
Clinically significant change in visual acuity 21 days Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam 21 days Ocular safety and tolerability: slit lamp
Incidence of systemic TEAEs 21 days Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP) 21 days Systemic safety and tolerability: vital signs
- Secondary Outcome Measures
Name Time Method CFB in IOP at various timepoints in the study eye up to 21 days Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye 21 days Ocular hypotensive efficacy: diurnal IOP CFB
Trial Locations
- Locations (1)
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, United States