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

Last updated: January 16, 2025
Sponsor: Qlaris Bio, Inc.
Overall Status: Completed

Phase

2

Condition

Williams Syndrome

Glaucoma

Ocular Hypertension

Treatment

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

QLS-111 ophthalmic vehicle solution

Timolol maleate Preservative Free 0.5% ophthalmic solution

Clinical Study ID

NCT06016972
QC-111-201
Osprey
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withdocumented 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

Exclusion Criteria:

  • IOP >34 mmHg

  • Severe glaucomatous damage that would preclude safe washout of prescribed ocularhypotensive medications

  • Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes,cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if doneno earlier than 1 year from study, some minimally invasive glaucoma surgeries areallowed if done no earlier than 1 year from study)

  • Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis ofeye

  • 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 previousenrollment and treatment with Qlaris investigational product

  • Pregnant or lactating

Study Design

Total Participants: 63
Treatment Group(s): 5
Primary Treatment: Experimental: QLS-111 ophthalmic solution, (0.03%)
Phase: 2
Study Start date:
March 05, 2024
Estimated Completion Date:
August 20, 2024

Study 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.

Connect with a study center

  • Coastal Research Associates, LLC

    Roswell, Georgia 30076
    United States

    Site Not Available

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