Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329791
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-19
Brief Title:
A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease DED
Sponsor:
Azura Ophthalmics
Organization:
Azura Ophthalmics
Study Overview
Official Title:
A Phase 3 Multicenter Vehicle-controlled Randomized Study to Evaluate the Efficacy Safety and Tolerability of AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Associated Symptoms of Dry Eye Disease DED
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 05 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
Detailed Description:
This study is designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 05 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 inclusionexclusion criteria will be randomized centrally to treatment in a 11 ratio
Study follow-up visits will be conducted on Day 14 Month 15 Month 3 Month 45 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
Following a Screening qualification period all patients diagnosed with abnormal meibomian gland function and associated symptoms of DED and meeting the inclusionexclusion criteria will be randomized centrally to treatment in a 11 ratio
Study follow-up visits will be conducted on Day 14 Month 15 Month 3 Month 45 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None