A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
Overview
- Phase
- Phase 2
- Intervention
- QLS-111 ophthalmic vehicle solution
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Sponsor
- Qlaris Bio, Inc.
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Clinically significant changes in heart rate (HR)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
QLS-111 ophthalmic vehicle solution
Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
Intervention: QLS-111 ophthalmic vehicle solution
Outcomes
Primary Outcomes
Clinically significant changes in heart rate (HR)
Time Frame: 21 days
Systemic safety and tolerability: vital signs
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Time Frame: 21 days
Ocular safety and tolerability: adverse events (AEs)
Clinically significant change in findings on fundus exam
Time Frame: 21 days
Ocular safety and tolerability: fundus
Clinically significant change in visual acuity
Time Frame: 21 days
Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam
Time Frame: 21 days
Ocular safety and tolerability: slit lamp
Incidence of systemic TEAEs
Time Frame: 21 days
Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)
Time Frame: 21 days
Systemic safety and tolerability: vital signs
Secondary Outcomes
- CFB in IOP at various timepoints in the study eye(up to 21 days)
- Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye(21 days)