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A Study to Evaluate Safety and Tolerability of QLS-101 in NTG

NCT04857827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-20

No results posted yet for this study

Summary

A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma

Conditions

  • Normal Tension Glaucoma (NTG)

Interventions

DRUG

QLS-101

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

DRUG

Timolol maleate PF 0.5% ophthalmic solution

Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

Sponsors & Collaborators

  • Qlaris Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • B. Wirostko, M.D. · Qlaris Bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-08-26
Completion
2022-08-26
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 NCT04857827 on ClinicalTrials.gov