A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)

AXR201701

Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).

2018-06-26

2018-12-28

2019-01-09

Completed

Early phase I

102

Inclusion Criteria: * Male or female, 18 years of age or older at screening visit * Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye * Reported history of dry eye for at least 6 months * Corneal fluorescein staining score ≥ 2 * Eye dryness score ≥ 40 * Total Ocular Surface Disease Index (OSDI) score \> 18 Exclusion Criteria: * Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease * Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure. * Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity * BCVA worse than 20/100 in either eye * Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye * Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells * Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea * Recent (within the past 3 months) ocular surgery, trauma or herpes * Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2023-10-13