At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
AXR-159 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating AXR-159 and Vehicle for Dry Eye. Completed, enrolled 102 participants across 3 sites.
Detailed 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).
Study Details
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionDec 2018
Study CompletionJan 2019
TodayJul 2026
First PostedJul 26, 2018
Enrollment StartJun 26, 2018
Primary CompletionDec 28, 2018
Study CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.9 years ago
Interventions
AXR-159drug
AXR-159 Ophthalmic Solution
Vehicledrug
AXR-159 Ophthalmic Solution Vehicle