A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease

Completed · Phase 2

Conditions studied: Dry Eye

In brief

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).

Key facts

Study ID

NCT03598699

Run by

AxeroVision, Inc.

People needed

102

Starts

2018-06-26

Expected to finish

2019-01-09

Last updated by the study team

2023-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Andover Eye Associates — Andover, Massachusetts, United States
• Andover Eye Associates — Raynham, Massachusetts, United States
• Total Eye Care, P.A. — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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