Eye Research Foundation | Newport Beach, CA
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About
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.
Full description
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.
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Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups, including a placebo group
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Central trial contact
Charles Bosworth, PhD; Marc Gleeson
Data sourced from clinicaltrials.gov
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