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

Qlaris Bio

Status and phase: Not yet enrolling; Phase 2

Conditions: Normal Tension Glaucoma (NTG); Glaucoma; Low-Tension Glaucoma, Bilateral; Low-Tension Glaucoma, Unspecified Eye

Treatments: Drug: QLS-111 ophthalmic solution (0.015%); Drug: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06030193

QC-111-202

Nightingale (Other Identifier)

Details and patient eligibility

About

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

QLS-111 ophthalmic solution

Experimental group

Description:

Qlaris' investigational product, QLS-111 ophthalmic solution, 0.15%, provided in single use vials, masked, and PF.

Treatment:

Drug: QLS-111 ophthalmic solution (0.015%)

Timolol maleate PF 0.5% Ophthalmic Solution

Active Comparator group

Description:

Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) provided in single use vials, masked.

Treatment:

Drug: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol)