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

Study Overview
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Brief Summary
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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
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A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus timolol maleate Preservative Free 0.5% ophthalmic solution and 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 timolol maleate PF 0.5% ophthalmic solution and 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 timolol maleate PF 0.5% ophthalmic solution and vehicle with QAM, QPM, and BID dosing.

Official Title
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A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 vs Timolol Maleate Preservative Free 0.5% Ophthalmic Solution and Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients

Conditions
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Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension (OHT)

Intervention / Treatment
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* Drug: Experimental: QLS-111 ophthalmic solution, (0.015%)
* Drug: Experimental: QLS-111 ophthalmic solution, (0.03%)
* Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)
* Drug: Timolol maleate Preservative Free 0.5% ophthalmic solution
* Other: QLS-111 ophthalmic vehicle solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 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 1.5 years from study) Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye Use of other ophthalmic concomitant medications during the study Known hypersensitivity to Timolol 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi site double masked, active- and vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111, Timolol, or vehicle. Both eyes (OU) will be dosed.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS-111 ophthalmic solution<br>Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.15%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF). | Drug: Experimental: QLS-111 ophthalmic solution, (0.015%)<br>* QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.<br>* Other names: QLS-111;Drug: Experimental: QLS-111 ophthalmic solution, (0.03%)<br>* QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.<br>* Other names: QLS-111;Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)<br>* QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.<br>* Other names: QLS-111;|
| Active Comparator: Timolol maleate Preservative Free 0.5% ophthalmic solution<br>Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF. | Drug: Timolol maleate Preservative Free 0.5% ophthalmic solution<br>* Timolol applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.<br>* Other names: Timoptic in Ocudose;|
| Placebo Comparator: QLS-111 ophthalmic vehicle solution<br>Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF. | Other: QLS-111 ophthalmic vehicle solution<br>* Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) | Ocular safety and tolerability: adverse events (AEs) | 21 days | 
| Clinically significant change in visual acuity | Ocular safety and tolerability: visual acuity | 21 days | 
| Clinically significant change in findings on slit lamp exam | Ocular safety and tolerability: slit lamp | 21 days | 
| Clinically significant change in findings on fundus exam | Ocular safety and tolerability: fundus | 21 days | 
| Incidence of systemic TEAEs | Systemic safety and tolerability: AEs | 21 days | 
| Clinically significant changes in blood pressure (BP) | Systemic safety and tolerability: vital signs | 21 days | 
| Clinically significant changes in heart rate (HR) | Systemic safety and tolerability: vital signs | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye | Ocular hypotensive efficacy: diurnal IOP CFB | 21 days | 
| CFB in IOP at various timepoints in the study eye | Ocular hypotensive efficacy: CFB for multiple timepoints throughout day | up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qlaris, POAG, OHT, IOP, Glaucoma, Osprey