Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension

Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Open-angle Glaucoma (OAG); Ocular Hypertension (OHT)
• Intervention / Treatment: Drug: QLS-111, 0.015%; Drug: QLS-111, 0.030%; Drug: QLS-111, 0.075%; Drug: QLS-111 vehicle ophthalmic solution

Detailed Description

Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Brandano; Phone Number: 9789302103; Email: lbrandano@qlaris.bio
• Study Contact Backup: Name: Daniel DeWalt; Email: ddewalt@qlaris.bio

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Recruiting
      • Berkeley Eye Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 12 years or older
• Able and willing provide signed informed consent (assent)
• mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., >20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
• IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization

Exclusion Criteria:

• History of active ocular disease other than mild to moderate OAG/OHT
• Nonresponse to and/or noncompliant with PGA treatment
• Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
• Moderate to severe glaucomatous damage in either eye
• Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
• significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
• Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
• Clinically significant retinal disease in either eye
• Clinically significant systemic or psychiatric disease
• Participation in any investigational study within 30 days prior to screening
• 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: Experimental: QLS-111 ophthalmic solution; Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.	Drug: QLS-111, 0.015%; QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.; Other Names: QLS-111; Drug: QLS-111, 0.030%; QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.; Other Names: QLS-111; Drug: QLS-111, 0.075%; QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.; Other Names: QLS-111
Placebo Comparator: Placebo comparator: Vehicle ophthalmic solution; Inactive control (0.00%), PF, single-use units, masked.	Drug: QLS-111 vehicle ophthalmic solution; Vehicle drops applied QPM for 14 days the BID for 14 days.; Other Names: Vehicle; inactive control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ocular treatment-emergent adverse events (TEAEs)	Ocular safety and tolerability	28 days
Clinically significant change in visual acuity	Ocular safety and tolerability	28 days
Clinically significant change in findings on slit lamp exam	Ocular safety and tolerability	28 days
Clinically significant change in findings on fundus exam	Ocular safety and tolerability	28 days
Incidence of systemic (TEAEs)	Systemic safety and tolerability	28 days
Clinically significant change in blood pressure	Systemic safety and tolerability	28 days
Clinically significant change in heart rate	Systemic safety and tolerability	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (CFB) of mean diurnal IOP in the study eye	Ocular hypotensive efficacy: diurnal IOP	28 days
CFB in IOP at various timepoints in the study eye	Ocular hypotensive efficacy: CFB for multiple timepoints	28 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): April 21, 2024
• Primary Completion (Estimated): October 5, 2024
• Study Completion (Estimated): October 5, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma; OAG; OHT; latanoprost; Qlaris; PGA therapy; Apteryx I
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: QC-111-203; Apteryx I (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