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

AxeroVision

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Vehicle; Drug: AXR-159

Study type: Interventional

Funder types: Industry

Identifiers

NCT03598699

AXR201701

Details and patient eligibility

About

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).

Full description

Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.

A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 4 patient groups, including a placebo group

AXR-159 Ophthalmic Solution 3 mg/mL

Experimental group

Description:

AXR-159 Low Dose

Treatment:

Drug: AXR-159

AXR-159 Ophthalmic Solution 30 mg/mL

Experimental group

Description:

AXR-159 Mid Dose

Treatment:

Drug: AXR-159

AXR-159 Ophthalmic Solution 50 mg/mL

Experimental group

Description:

AXR-159 High Dose

Treatment:

Drug: AXR-159

AXR-159 Ophthalmic Solution Vehicle

Placebo Comparator group

Description:

Control Group

Treatment:

Drug: Vehicle