Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients

Qlaris Bio

Status and phase: Completed; Phase 2

Conditions: Primary Open Angle Glaucoma (POAG); Primary Open Angle Glaucoma of Both Eyes; Primary Open-Angle Glaucoma, Unspecified Eye; Ocular Hypertension (OHT)

Treatments: Drug: Experimental: QLS-111 ophthalmic solution, (0.015%); Drug: Experimental: QLS-111 ophthalmic solution, (0.03%); Drug: Experimental: QLS-111 ophthalmic solution, (0.075%); Other: QLS-111 ophthalmic vehicle solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06016972

QC-111-201

Osprey (Other Identifier)

Details and patient eligibility

About

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.

Full description

A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Able to provide written acknowledgement of giving informed consent
• Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
• Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2

Exclusion criteria

• IOP >34 mmHg
• 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 year from study)
• Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
• Use of other ophthalmic concomitant medications during the study
• 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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63 participants in 2 patient groups, including a placebo group

QLS-111 ophthalmic solution

Experimental group

Description:

Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).

Treatment:

Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)

Drug: Experimental: QLS-111 ophthalmic solution, (0.03%)

Drug: Experimental: QLS-111 ophthalmic solution, (0.015%)

QLS-111 ophthalmic vehicle solution

Placebo Comparator group

Description:

Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.

Treatment:

Other: QLS-111 ophthalmic vehicle solution