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

Primary Purpose

Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Experimental: QLS-111 ophthalmic solution, (0.015%)

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

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

Timolol maleate Preservative Free 0.5% ophthalmic solution

QLS-111 ophthalmic vehicle solution

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma (POAG) focused on measuring Qlaris, POAG, OHT, IOP, Glaucoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QLS-111 ophthalmic solution

Timolol maleate Preservative Free 0.5% ophthalmic solution

QLS-111 ophthalmic vehicle solution

Arm Description

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).

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

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

Outcomes

Primary Outcome Measures

Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)

Ocular safety and tolerability: adverse events (AEs)

Clinically significant change in visual acuity

Ocular safety and tolerability: visual acuity

Clinically significant change in findings on slit lamp exam

Ocular safety and tolerability: slit lamp

Clinically significant change in findings on fundus exam

Ocular safety and tolerability: fundus

Incidence of systemic TEAEs

Systemic safety and tolerability: AEs

Clinically significant changes in blood pressure (BP)

Systemic safety and tolerability: vital signs

Clinically significant changes in heart rate (HR)

Systemic safety and tolerability: vital signs

Secondary Outcome Measures

Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye

Ocular hypotensive efficacy: diurnal IOP CFB

CFB in IOP at various timepoints in the study eye

Ocular hypotensive efficacy: CFB for multiple timepoints throughout day

Full Information

NCT ID

NCT06016972

First Posted

August 18, 2023

Last Updated

August 30, 2023

Sponsor

Qlaris Bio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT06016972

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 11, 2023 (Anticipated)

Primary Completion Date

December 18, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qlaris Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Qlaris, POAG, OHT, IOP, Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

QLS-111 ophthalmic solution

Arm Type

Experimental

Arm Description

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).

Arm Title

Timolol maleate Preservative Free 0.5% ophthalmic solution

Arm Type

Active Comparator

Arm Description

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

Arm Title

QLS-111 ophthalmic vehicle solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Experimental: QLS-111 ophthalmic solution, (0.015%)

Other Intervention Name(s)

QLS-111

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

QLS-111

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

QLS-111

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Timolol maleate Preservative Free 0.5% ophthalmic solution

Other Intervention Name(s)

Timolol, Timoptic in Ocudose

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

QLS-111 ophthalmic vehicle solution

Other Intervention Name(s)

vehicle, placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)

Description

Ocular safety and tolerability: adverse events (AEs)

Time Frame

21 days

Title

Clinically significant change in visual acuity

Description

Ocular safety and tolerability: visual acuity

Time Frame

21 days

Title

Clinically significant change in findings on slit lamp exam

Description

Ocular safety and tolerability: slit lamp

Time Frame

21 days

Title

Clinically significant change in findings on fundus exam

Description

Ocular safety and tolerability: fundus

Time Frame

21 days

Title

Incidence of systemic TEAEs

Description

Systemic safety and tolerability: AEs

Time Frame

21 days

Title

Clinically significant changes in blood pressure (BP)

Description

Systemic safety and tolerability: vital signs

Time Frame

21 days

Title

Clinically significant changes in heart rate (HR)

Description

Systemic safety and tolerability: vital signs

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye

Description

Ocular hypotensive efficacy: diurnal IOP CFB

Time Frame

21 days

Title

CFB in IOP at various timepoints in the study eye

Description

Ocular hypotensive efficacy: CFB for multiple timepoints throughout day

Time Frame

up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa Brandano

Phone

9789302103

lbrandano@qlaris.bio

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel DeWalt

ddewalt@qlaris.bio

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Brandano

Organizational Affiliation

Qlaris Bio, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://qlaris.bio

Description

Company website, pipeline

Learn more about this trial

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

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