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

NCT06249152 | Completed Phase 2 FDA Drug

• 2 other identifiers: QC-111-203Apteryx
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-angle Glaucoma (OAG); Ocular Hypertension (OHT); Glaucoma

Keywords

Qlaris; OAG; Glaucoma; PGA therapy; Apteryx I; OHT; latanoprost

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Change from baseline (CFB) of mean diurnal IOP in the study eye

  28 days

• CFB in IOP at various timepoints in the study eye

  28 days

Study Arms (2)

Experimental: QLS-111 ophthalmic solution

EXPERIMENTAL

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%; Drug: QLS-111, 0.030%; Drug: QLS-111, 0.075%

Placebo comparator: Vehicle ophthalmic solution

PLACEBO COMPARATOR

Inactive control (0.00%), PF, single-use units, masked.

Drug: QLS-111 vehicle ophthalmic solution

Interventions

QLS-111, 0.015% DRUG

QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.

Also known as: QLS-111

Experimental: QLS-111 ophthalmic solution

QLS-111, 0.030% DRUG

QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.

Also known as: QLS-111

Experimental: QLS-111 ophthalmic solution

QLS-111, 0.075% DRUG

QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.

Also known as: QLS-111

Experimental: QLS-111 ophthalmic solution

QLS-111 vehicle ophthalmic solution DRUG

Vehicle drops applied QPM for 14 days the BID for 14 days.

Also known as: Vehicle, inactive control

Placebo comparator: Vehicle ophthalmic solution

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

Related Links

• Company website, pipeline

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Lisa Brandano

  Qlaris Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, investigators, study staff, Sponsor and designates involved in the conduct, monitoring and outcome evaluation of the study will be masked to IP assignment identity until final database lock is complete. IP will be provided in in identical packaging. Unmasked statistician will prepare the randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-site, double-masked, vehicle-controlled randomized prospective, parallel study of 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: April 21, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)