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

Phase 2
Waitlist Available
Research Sponsored by Qlaris Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 86 days
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two eye drop treatments, QLS-101 and timolol maleate, in people with normal tension glaucoma. Normal tension glaucoma patients have optic nerve damage despite normal eye pressure. Timolol maleate works by reducing fluid production in the eye, while QLS-101's exact mechanism is not specified but aims to protect eye health.

Eligible Conditions
  • Glaucoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~86 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 86 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular safety
Secondary study objectives
Ocular hypotensive efficacy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: QLS-101 ophthalmic solution 2.0%Experimental Treatment1 Intervention
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Group II: QLS-101 ophthalmic solution 1.0%Experimental Treatment1 Intervention
Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
Group III: Timolol maleate PF 0.5% ophthalmic solutionActive Control2 Interventions
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QLS-101
2021
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Qlaris Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
257 Total Patients Enrolled
6 Trials studying Glaucoma
257 Patients Enrolled for Glaucoma
Qlaris BioStudy ChairWellesley, MA
B. Wirostko, M.D.Study DirectorQlaris Bio, Inc.
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Glaucoma
3 Patients Enrolled for Glaucoma
~7 spots leftby Dec 2025
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