A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)

Launched by AZURA OPHTHALMICS · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AZR-MD-001 for people who have Dry Eye Disease (DED) caused by problems with the meibomian glands, which help keep our eyes lubricated. The trial will involve applying a special ointment either containing the study treatment or a placebo (a non-active version) to the eyes twice a week at bedtime for up to a year. Researchers want to see if this treatment can improve eye comfort and function for those affected by DED.

To participate in this trial, you need to be at least 18 years old and have signs of evaporative dry eye and blocked meibomian glands in both eyes. Unfortunately, if you have certain eye conditions like glaucoma or have had recent eye surgery, you may not be eligible. Participants will be closely monitored throughout the study, and it’s important to note that you will need to avoid other treatments for dry eyes during this time. This study is currently ongoing and is not recruiting new participants right now.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, 18 years of age or older at Screening.
• • Evidence of active Evaporative DED at Screening and Baseline.
• • Evidence of meibomian gland obstruction in both eyes at Screening and Baseline.
• Exclusion Criteria:
• • Ocular disease (except for Meibomian Gland Dysfunction (MGD) and DED/keratoconjunctivitis sicca) or systemic disease determined to be uncontrolled by the investigator.
• • Patient has glaucoma, ocular hypertension, or an intraocular pressure (IOP) of ≥24 mm Hg in either eye at Screening.
• • Recent (within the past 3 months of Screening) ocular surgery, trauma, herpes, or recurrent inflammation.
• • Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration.