NCT03598699

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: AxeroVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	AXR-159	AXR-159 Ophthalmic Solution
DRUG	Vehicle	AXR-159 Ophthalmic Solution Vehicle

Timeline

• Start date: 2018-06-26
• Primary completion: 2018-12-28
• Completion: 2019-01-09
• First posted: 2018-07-26
• Last updated: 2023-10-13
• Results posted: 2023-10-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study