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

NCT06016972 | Completed Phase 2 FDA Drug

• 2 other identifiers: QC-111-201Osprey
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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; Osprey

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

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

  21 days

• CFB in IOP at various timepoints in the study eye

  up to 21 days

Study Arms (2)

QLS-111 ophthalmic solution

EXPERIMENTAL

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%); Drug: Experimental: QLS-111 ophthalmic solution, (0.03%); Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)

QLS-111 ophthalmic vehicle solution

PLACEBO COMPARATOR

Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.

Other: QLS-111 ophthalmic vehicle solution

Interventions

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

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.

Also known as: QLS-111

QLS-111 ophthalmic solution

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

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.

Also known as: QLS-111

QLS-111 ophthalmic solution

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

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.

Also known as: QLS-111

QLS-111 ophthalmic solution

QLS-111 ophthalmic vehicle solution OTHER

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.

Also known as: vehicle, placebo

QLS-111 ophthalmic vehicle solution

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Coastal Research Associates, LLC

Roswell, Georgia, 30076, 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 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 packaging. Unmasked statistician preparing the masked 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 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 or vehicle. Both eyes (OU) will be dosed.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: March 5, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)