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A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)

NCT03652051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2024-02-28

Study results available
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Summary

AZ201801 is a multicenter study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) and evaporative Dry Eye Disease (DED)

Conditions

  • Meibomian Gland Dysfunction
  • Dry Eye

Interventions

DRUG

AZR-MD-001 Low Dose

AZR-MD-001 is an ophthalmic ointment

DRUG

AZR-MD-001 Mid Dose

AZR-MD-001 is an ophthalmic ointment

DRUG

AZR-MD-001 High Dose

AZR-MD-001 is an ophthalmic ointment

DRUG

AZR-MD-001 Vehicle

AZR-MD-001 is a vehicle ophthalmic ointment

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Cliantha Research

    collaborator OTHER

  • Azura Ophthalmics

    lead INDUSTRY

Principal Investigators

  • Stephanie L Watson · Save Sight Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2022-09-14
Completion
2022-10-19
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

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 NCT03652051 on ClinicalTrials.gov