A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension

QC-111-203

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.

2024-04-21

2024-10-05

2024-10-05

Recruiting

Early phase I

48

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-site, double-masked, vehicle-controlled randomized prospective, parallel study of 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Study subjects, investigators, study staff, Sponsor and designates involved in the conduct, monitoring and outcome evaluation of the study will be masked to IP assignment identity until final database lock is complete. IP will be provided in in identical packaging. Unmasked statistician will prepare the randomization schedule.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2024-04-25