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

Sponsor

Qlaris Bio, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06016972

Collaborator

(none)

120

Enrollment

Arms

12.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma (POAG) Primary Open Angle Glaucoma of Both Eyes Primary Open-Angle Glaucoma, Unspecified Eye Ocular Hypertension (OHT)	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	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 11, 2023

Anticipated Primary Completion Date :

Dec 18, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QLS-111 ophthalmic solution 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%) 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. Other Names: QLS-111 Drug: Experimental: QLS-111 ophthalmic solution, (0.03%) 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. Other Names: QLS-111 Drug: Experimental: QLS-111 ophthalmic solution, (0.075%) 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. Other Names: QLS-111
Active Comparator: Timolol maleate Preservative Free 0.5% ophthalmic solution Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF.	Drug: Timolol maleate Preservative Free 0.5% ophthalmic solution 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. Other Names: Timolol Timoptic in Ocudose
Placebo Comparator: QLS-111 ophthalmic vehicle solution Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.	Other: QLS-111 ophthalmic vehicle solution 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. Other Names: vehicle placebo

Arm

Intervention/Treatment

Experimental: QLS-111 ophthalmic solution

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%)

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.

Other Names:

QLS-111

Drug: Experimental: QLS-111 ophthalmic solution, (0.03%)

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.

Other Names:

QLS-111

Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)

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.

Other Names:

QLS-111

Active Comparator: Timolol maleate Preservative Free 0.5% ophthalmic solution

Active control. Timolol maleate Preservative Free 0.5% ophthalmic solution, single use vials, masked, PF.

Drug: Timolol maleate Preservative Free 0.5% ophthalmic solution

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.

Other Names:

Timolol

Timoptic in Ocudose

Placebo Comparator: QLS-111 ophthalmic vehicle solution

Inactive control. QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.

Other: QLS-111 ophthalmic vehicle solution

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.

Other Names:

vehicle

placebo

Outcome Measures

Primary Outcome Measures

Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [21 days]
Ocular safety and tolerability: adverse events (AEs)
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
Clinically significant change in findings on fundus exam [21 days]
Ocular safety and tolerability: fundus
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
Clinically significant changes in heart rate (HR) [21 days]
Systemic safety and tolerability: vital signs

Secondary Outcome Measures

Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [21 days]
Ocular hypotensive efficacy: diurnal IOP CFB
CFB in IOP at various timepoints in the study eye [up to 21 days]
Ocular hypotensive efficacy: CFB for multiple timepoints throughout day

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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