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

Sponsor

Qlaris Bio, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04857827

Collaborator

(none)

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Normal Tension Glaucoma	Drug: QLS-101	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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 IP identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

Aug 29, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QLS-101 ophthalmic solution 1.0% Ophthalmic solution one time daily for 14 days (These patients will administer 2.0% QLS-101 for last 14 days of the study).	Drug: QLS-101 Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
Active Comparator: Timolol maleate PF 0.5% ophthalmic solution Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.	Drug: QLS-101 Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
Experimental: QLS-101 ophthalmic solution 2% Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.	Drug: QLS-101 Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.

Arm

Intervention/Treatment

Experimental: QLS-101 ophthalmic solution 1.0%

Ophthalmic solution one time daily for 14 days (These patients will administer 2.0% QLS-101 for last 14 days of the study).

Drug: QLS-101