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

A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04857827

Enrollment

Registered

2021-04-23

Start date

2021-09-15

Completion date

2022-08-26

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Tension Glaucoma (NTG)

Keywords

low tension glaucoma (LTG), glaucoma

Brief 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

Interventions

DRUGQLS-101

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

DRUGTimolol maleate PF 0.5% ophthalmic solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Visual acuity +1.0 logMAR or better 2. Willing to give informed consent 3. Ability to washout from current intraocular pressure lowering medications -

Exclusion criteria

1. All secondary glaucomas 2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening) 3. Refractive surgery 4. Ocular infection or inflammation

Design outcomes

Primary

Measure	Time frame	Description
Ocular safety	86 days	Number of participants with treatment-related adverse events will be monitored

Secondary

Measure	Time frame	Description
Ocular hypotensive efficacy	14 days	Number of participants with intraocular pressure reduction from baseline will be calculated

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026