A Phase 3 interventional study of AZR-MD-001 and Vehicle in Dry Eye Disease, sponsored by Azura Ophthalmics. Active, not recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Azura Ophthalmics · Phase 3, Interventional, and Treatment
This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months.
Following a Screening qualification period, all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED, and meeting the inclusion/exclusion criteria, will be randomized centrally, to treatment in a 1:1 ratio.
Study follow-up visits will be conducted on Day 14, Month 1.5, Month 3, Month 4.5, Month 6, Month 9, and Month 12. Patients will exit the study approximately 13 months after the Baseline visit. Any ongoing treatment-emergent adverse events (TEAEs) will be followed for an additional 30 days following the Month 12 visit.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Azura Ophthalmics is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AZR-MD-001 sterile ophthalmic ointment 0.5% to be administered twice weekly at bedtime.
Drug: AZR-MD-001
AZR-MD-001 Vehicle to be administered twice weekly at bedtime.
Other: Vehicle
AZR-MD-001 sterile ophthalmic ointment 0.5%
Also known as: AZR-MD-001 ophthalmic ointment 0.5%
AZR-MD-001 Vehicle
Also known as: AZR-MD-001 Vehicle
Change from baseline in Meibomian Glands Yielding Liquid Secretion
Meibomian Glands Yielding Liquid Secretion (MGYLS) measures the number of meibomian glands (0 - 15) secreting liquid
Time frame: Month 3
Change from baseline in Total Ocular Surface Disease Index Score
The Total Ocular Surface Disease Index Score (OSDI) provides a score from 0 (normal) to 100 (abnormal)
Time frame: Month 3
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Azura Ophthalmics