A Randomized, Vehicle-controlled, Double-masked Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Subjects With Normal Tension Glaucoma (NTG)

QC-111-202

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

2024-06-10

2025-02-17

2025-03-07

Not yet recruiting

Early phase I

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen \\[21-day treatment period\\])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical appearing packaging. Unmasked statistician preparing the masked randomization schedule.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-01-29