NCT05548491

Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)

A Two Stage, Multi-center, Vehicle-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZR-MD-001 and to Determine Common Symptoms in Contact Lens Discomfort (CLD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Azura Ophthalmics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. For Stage 1 of the study, up to 12 participants who experience symptoms of CLD and experience concomitant meibomian gland dysfunction will complete a Screening visit followed by a hybrid concept elicitation and cognitive debriefing interview which can occur at the end of the Screening visit or up to 14 days later. Stage 2 is a multi-center, single-masked, vehicle-controlled, randomized, parallel group study. Participants with CLD will be randomly assigned in a 1:1 ratio to receive either active AZR-MD-001 ointment/semi-solid drug (1.0%) or AZR-MD-001 vehicle for 3 months.

Conditions

• Contact Lens Discomfort

Interventions

Type	Name	Description
DRUG	AZR-MD-001 ointment/semi-solid drug	ointment/semi-solid drug

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2022-09-21
• Last updated: 2023-10-18

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study