Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)

Sponsor
Azura Ophthalmics (Industry)
Overall Status
Completed
CT.gov ID
NCT04314362
Collaborator
The University of New South Wales (Other)
29
Enrollment
1
Location
3
Arms
5.8
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: AZR-MD-001 ointment/semi-solid drug
Phase 2/Phase 3

Detailed Description

Randomized study with 6 visits. For all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). At the end of the qualification period patients who still exhibit signs of Meibomian Gland Dysfunction (MGD) at the baseline visit will be enrolled into a 3-month treatment period. At the baseline (Day 0) visit, patients will be randomly assigned to receive either AZR-MD-001 ointment/semi-solid drug or AZR-MD-001 vehicle twice-weekly.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
A Single-center, Vehicle-controlled, Study to Evaluate Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
Actual Study Start Date :
Jul 14, 2020
Actual Primary Completion Date :
Jan 6, 2021
Actual Study Completion Date :
Jan 6, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: AZR-MD-001 Active

AZR-MD-001 ointment/semi-solid drug (1.0%)

Drug: AZR-MD-001 ointment/semi-solid drug
AZR-MD-001 (1.0%) and suitable excipient

Experimental: AZR-MD-001 Active + Conventional Treatment

AZR-MD-001 ointment/semi-solid drug (1.0%) plus Hylo-Forte®

Drug: AZR-MD-001 ointment/semi-solid drug
AZR-MD-001 (1.0%) and suitable excipient

Experimental: AZR-MD-001 vehicle

AZR-MD-001 vehicle control

Drug: AZR-MD-001 ointment/semi-solid drug
AZR-MD-001 (1.0%) and suitable excipient

Outcome Measures

Primary Outcome Measures

  1. Primary efficacy for MGD: change from baseline in meibomian gland secretion score (MGS) [Day 14 to Month 3]

    The MGS can range from 0 (highly abnormal) to 45 (Normal)

  2. Adverse Events [Baseline to Month 3]

    Observed rate of Adverse Events

Secondary Outcome Measures

  1. Total OSDI: change from baseline in Total OSDI [Day 14 to Month 3]

    Total OSDI can range in value from 0 (Normal) to 100 (Highly Abnormal)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit

  • Reported dry eye signs and symptoms within the past 3 months:

Ocular Surface Disease Index (OSDI) score ≥ 13; TBUT < 10 seconds in both eyes

Exclusion Criteria:
  • Uncontrolled ocular disease (except for MGD) or uncontrolled systemic disease

  • Patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (IOP) in either eye at screening of ≥24 mm Hg determined by Goldman applanation tonometry or has planned insertion/removal of glaucoma filtration shunts/devices during the study

  • Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity

  • Recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation

  • Contact lens use anticipated during the study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Fiona StapletonSydneyNew South WalesAustralia

Sponsors and Collaborators

  • Azura Ophthalmics
  • The University of New South Wales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Azura Ophthalmics
ClinicalTrials.gov Identifier:
NCT04314362
Other Study ID Numbers:
  • SOVS2020-080
First Posted:
Mar 19, 2020
Last Update Posted:
Jan 11, 2021
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2021