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

Phase 2

Completed

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

• Registration Number: NCT06249152
• Lead Sponsor: Qlaris Bio, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Start: 2024-04-21
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: QLS-111 ophthalmic solution	QLS-111, 0.015%	Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
Experimental: QLS-111 ophthalmic solution	QLS-111, 0.030%	Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
Experimental: QLS-111 ophthalmic solution	QLS-111, 0.075%	Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
Placebo comparator: Vehicle ophthalmic solution	QLS-111 vehicle ophthalmic solution	Inactive control (0.00%), PF, single-use units, masked.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline (CFB) of mean diurnal IOP in the study eye	28 days	Ocular hypotensive efficacy: diurnal IOP
CFB in IOP at various timepoints in the study eye	28 days	Ocular hypotensive efficacy: CFB for multiple timepoints

Trial Locations

Locations (1)

Berkeley Eye Center; 🇺🇸 Houston, Texas, United States