Last reviewed · How we verify
NCT05548491
Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
Phase 2 trial testing AZR-MD-001 ointment/semi-solid drug in Contact Lens Discomfort in 67 participants. Completed in 13 October 2023.
13 October 2023
Quick facts
| Lead sponsor | Azura Ophthalmics |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 10 November 2022 |
| Primary completion | 13 October 2023 |
| Estimated completion | 13 October 2023 |
| Sites | 2 locations across Australia |
Drugs / interventions tested
- AZR-MD-001 ointment/semi-solid drug — full drug profile →
Conditions studied
- Contact Lens Discomfort — all drugs for Contact Lens Discomfort →
Sponsor
Azura Ophthalmics — full company profile →
Who can join
18 and older, any sex, with Contact Lens Discomfort. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A two stage, multi-center, vehicle-controlled study to determine common symptoms in patients with Contact Lens Discomfort (CLD) in Stage 1 and to evaluate the safety, tolerability, and pharmacodynamics of AZR-MD-001 in Stage 2.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacological, Natural and Emerging Therapies for Meibomian Gland Dysfunction: A Review.
Cooper JM, Mahmoud R, Jennings CJ, Bandamwar K, et al · · 2026 · PMID 41931217 · DOI 10.1007/s40265-025-02241-6
Verify or expand the search:
- PubMed search for NCT05548491
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZR-MD-001 ointment/semi-solid drug
Trials testing the same drug.
- NCT04314362 — Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD) · Phase 2, PHASE3 · completed
Other recruiting trials for Contact Lens Discomfort
Currently open trials in the same condition.
- NCT03652337 — Meibomian Gland Dysfunction Management · NA · active not recruiting
Other Azura Ophthalmics trials
Trials by the same sponsor.
- 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
- NCT03972501 — An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD) · 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
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05548491 (US National Library of Medicine, public domain)
- 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: 18 October 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/NCT05548491.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing