Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

Qlaris Bio

Status and phase: Enrolling; Phase 2

Conditions: Glaucoma; Open-angle Glaucoma (OAG); Ocular Hypertension (OHT)

Treatments: Drug: QLS-111 vehicle ophthalmic solution; Drug: QLS-111, 0.015%; Drug: QLS-111, 0.030%; Drug: QLS-111, 0.075%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06249152

QC-111-203

Apteryx I (Other Identifier)

Details and patient eligibility

About

Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.

Full description

Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.

Enrollment: 48 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years or older
• Able and willing provide signed informed consent (assent)
• mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., >20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
• IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization

Exclusion criteria

• History of active ocular disease other than mild to moderate OAG/OHT
• Nonresponse to and/or noncompliant with PGA treatment
• Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
• Moderate to severe glaucomatous damage in either eye
• Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
• significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
• Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
• Clinically significant retinal disease in either eye
• Clinically significant systemic or psychiatric disease
• Participation in any investigational study within 30 days prior to screening
• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups, including a placebo group

Experimental: QLS-111 ophthalmic solution

Experimental group

Description:

Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.

Treatment:

Drug: QLS-111, 0.075%

Drug: QLS-111, 0.030%

Drug: QLS-111, 0.015%

Placebo comparator: Vehicle ophthalmic solution

Placebo Comparator group

Description:

Inactive control (0.00%), PF, single-use units, masked.

Treatment:

Drug: QLS-111 vehicle ophthalmic solution