Study of an Investigational Product, QLS-111, Provided As an Eyedrop, for Treatment of Normal Tension Glaucoma (NTG)

Phase 2

Not yet recruiting

• Conditions: Normal Tension Glaucoma (NTG); Low-Tension Glaucoma, Unspecified Eye; Low-Tension Glaucoma, Bilateral; Glaucoma
• Interventions: Drug: QLS-111 ophthalmic solution (0.015%); Drug: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)

• Registration Number: NCT06030193
• Lead Sponsor: Qlaris Bio, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Study Start: 2025-04-25
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 30 years or older
• Able to provide written acknowledgement of giving informed consent
• Best corrected visual acuity (BCVA) 20/200 or better
• NTG in one or both eyes with untreated IOP <21 mmHg at Visit 2 and morning assessment of Visit 3; IOP at morning assessment on Visits 2 and 3 doesn't differ more than 2 mmHg; has open iridocorneal angles, historic IOP <22 mmHg in either eye

Exclusion Criteria

• History of angle closure glaucoma, narrow or occludable angle on gonioscope
• All secondary glaucomas
• Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
• Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1.5 years from study)
• Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
• Use of other ophthalmic concomitant medications during the study
• Refractive surgery
• Uncontrolled hypertension or hypotension
• Significant systemic or psychiatric disease
• Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
• Pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLS-111 ophthalmic solution	QLS-111 ophthalmic solution (0.015%)	Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.
Timolol maleate PF 0.5% Ophthalmic Solution	Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)	Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked.

Primary Outcome Measures

Name	Time	Method
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)	14 days	Ocular safety and tolerability: (AEs)
Clinically significant change in visual acuity	14 days	Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam	14 days	Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
Clinically significant change in findings on fundus exam	14 days	Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
Incidence of systemic TEAEs	14 days	Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)	14 days	Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
Clinically significant changes in heart rate (HR)	14 days	Systemic safety and tolerability: vital signs

Secondary Outcome Measures

Name	Time	Method
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye	14 days	Ocular hypotensive efficacy: diurnal IOP CFB
CFB in IOP at various timepoints in the study eye	14 days	Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day

Trial Locations

Locations (1)

To be determined; 🇰🇷 Seoul, Korea, Republic of