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

NCT03598699 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-10-13

Study results available
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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).

Conditions

  • Dry Eye

Interventions

DRUG

AXR-159

AXR-159 Ophthalmic Solution

DRUG

Vehicle

AXR-159 Ophthalmic Solution Vehicle

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • AxeroVision, Inc.

    lead INDUSTRY

Principal Investigators

  • Gail L Torkildson, MD · Andover Eye Associates, 138 Haverhill Street, Andover MA 01810

  • Kenneth R Kenyon, MD · Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767

  • Eugene McLaurin, MD · Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2018-12-28
Completion
2019-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598699 on ClinicalTrials.gov