NCT04857827

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-08-26
• Completion: 2022-08-26
• First posted: 2021-04-23
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study