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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-01-09

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AXR-159 Ophthalmic Solution 3 mg/mL

AXR-159 Low Dose

Group Type EXPERIMENTAL

AXR-159

Intervention Type DRUG

AXR-159 Ophthalmic Solution

AXR-159 Ophthalmic Solution 30 mg/mL

AXR-159 Mid Dose

Group Type EXPERIMENTAL

AXR-159

Intervention Type DRUG

AXR-159 Ophthalmic Solution

AXR-159 Ophthalmic Solution 50 mg/mL

AXR-159 High Dose

Group Type EXPERIMENTAL

AXR-159

Intervention Type DRUG

AXR-159 Ophthalmic Solution

AXR-159 Ophthalmic Solution Vehicle

Control Group

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

AXR-159 Ophthalmic Solution Vehicle

Interventions

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AXR-159

AXR-159 Ophthalmic Solution

Intervention Type DRUG

Vehicle

AXR-159 Ophthalmic Solution Vehicle

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No