A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease (DED)

• Status: Completed
• Trial end date: 2021-01-12
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AxeroVision, Inc.
• Collaborator: ORA, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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