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

NCT06016972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-01-20

No results posted yet for this 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.

Conditions

  • Primary Open Angle Glaucoma (POAG)
  • Primary Open Angle Glaucoma of Both Eyes
  • Primary Open-Angle Glaucoma, Unspecified Eye
  • Ocular Hypertension (OHT)

Interventions

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

OTHER

QLS-111 ophthalmic vehicle solution

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.

Sponsors & Collaborators

  • Qlaris Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Brandano · Qlaris Bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2024-08-20
Completion
2024-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016972 on ClinicalTrials.gov