18 and older, any sex, with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibum Gland Secretion Score (MGS).Primary· Month 4
The MGS can range from 0 (highly abnormal) to 45 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. For each of the 15 glands, expressed secretion characteristics were graded on a 0-3 scale using the methods published by Lane and colleagues (2012).
Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment
Group
Value
95% CI
AZR-MD-001 Vehicle
12.1
± 10.7
AZR-MD-001 Active Dose
16
± 11.3
Primary Efficacy for MGD: Change From Baseline to Month 4 in Meibomian Glands Yielding Liquid Secretion (MGYLS).Primary· Month 4
The MGYLS can range from 0 (highly abnormal) to 15 (Normal). Meibomian gland assessment was completed using a handheld instrument, Meibomian Gland Evaluator, along the eyelid margin to ensure measurement consistency. A total of 15 glands were evaluated along the lower eyelid margin, consisting of 5 glands located in each of the temporal, central and nasal regions. The number of glands secreting any liquid were counted using the methods published by Lane and colleagues (2012).
Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction (
Group
Value
95% CI
AZR-MD-001 Vehicle
3.9
± 3.2
AZR-MD-001 Active Dose
4.1
± 4.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 Months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04391959 — Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
· Phase 2
· completed
NCT03652051 — A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (
· Phase 2
· completed
Other Azura Ophthalmics trials
Trials by the same sponsor.
NCT05548491 — Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
· Phase 2
· completed
NCT04391959 — Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
· Phase 2
· completed
NCT04314362 — Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD)
· Phase 2, PHASE3
· completed
NCT03652051 — A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azura Ophthalmics
Last refreshed: 25 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03972501.