A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
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
Study Type: Interventional (Clinical Trial)
Estimated 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: September 15, 2021
Estimated Primary Completion Date: June 2022
Estimated Study Completion Date: June 2022
Arm:
- Experimental: QLS-101 ophthalmic solution 1.0%
- Active Comparator: Timolol maleate PF 0.5% ophthalmic solution
- Experimental: QLS-101 ophthalmic solution 2%
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 30 |
| Actual Study start date | 15 September 2021 |
| Estimated Study Completion Date | 01 June 2022 |