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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma of Both Eyes; Primary Open Angle Glaucoma (POAG); Primary Open-Angle Glaucoma, Unspecified Eye; Ocular Hypertension (OHT)
• Intervention / Treatment: Drug: Experimental: QLS-111 ophthalmic solution, (0.015%); Drug: Experimental: QLS-111 ophthalmic solution, (0.03%); Drug: Experimental: QLS-111 ophthalmic solution, (0.075%); Other: QLS-111 ophthalmic vehicle solution

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS-111 ophthalmic solution; Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 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
Placebo Comparator: QLS-111 ophthalmic vehicle solution; Inactive control (0.00%). 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: placebo; vehicle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qlaris Bio, Inc.
• Investigators: Study Director: Lisa Brandano, Qlaris Bio, Inc.

Publications and helpful links

Helpful Links

• Company website, pipeline

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: POAG; Glaucoma; IOP; OHT; Qlaris; Osprey
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Hypertension; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: QC-111-201; Osprey (Other Identifier: Qlaris Bio, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No