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

Phase 2

Completed

• Conditions: Normal Tension Glaucoma (NTG)
• Interventions: Drug: QLS-101; Drug: Timolol maleate PF 0.5% ophthalmic solution

• Registration Number: NCT04857827
• Lead Sponsor: Qlaris Bio, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2021-09-15
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Disposition First Submitted: 2023-03-21
• Disposition First Posted: 2023-03-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLS-101 ophthalmic solution 1.0%	QLS-101	Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
Timolol maleate PF 0.5% ophthalmic solution	Timolol maleate PF 0.5% ophthalmic solution	Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
QLS-101 ophthalmic solution 2.0%	QLS-101	Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.

Primary Outcome Measures

Name	Time	Method
Ocular safety	86 days	Number of participants with treatment-related adverse events will be monitored

Secondary Outcome Measures

Name	Time	Method
Ocular hypotensive efficacy	14 days	Number of participants with intraocular pressure reduction from baseline will be calculated

Trial Locations

Locations (1)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States