Trials / Completed
CompletedNCT06030193
Study of an Investigational Product, QLS-111, Provided as an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)
A Randomized, Active-controlled, Multi-site, Double-masked, Pilot Study to Evaluate the Safety and Tolerability of QLS-111 Versus Timolol Maleate Preservative Free 0.5% Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Qlaris Bio, Inc. · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
Detailed description
A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol). Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.
Conditions
- Normal Tension Glaucoma (NTG)
- Low-Tension Glaucoma, Bilateral
- Low-Tension Glaucoma, Unspecified Eye
- Glaucoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QLS-111 ophthalmic solution (0.015%) | QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials. |
| DRUG | Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) | Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials. |
Timeline
- Start date
- 2025-08-13
- Primary completion
- 2026-02-23
- Completion
- 2026-03-23
- First posted
- 2023-09-08
- Last updated
- 2026-04-03
Locations
1 site across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06030193. Inclusion in this directory is not an endorsement.