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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2023

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.

Interventions

  • Drug: AZR-MD-001 ointment/semi-solid drug
    • ointment/semi-solid drug

Arms, Groups and Cohorts

  • Experimental: AZR-MD-001 1.0%
    • AZR-MD-001 ointment/semi-solid drug (1.0%)
  • Placebo Comparator: AZR-MD-001 vehicle
    • AZR-MD-001 vehicle

Clinical Trial Outcome Measures

Primary Measures

  • Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
    • Time Frame: 3 months
    • Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)
  • CLDEQ-8 fluctuating vision
    • Time Frame: 3 months
    • Change from baseline to month 3 in CLDEQ-8 fluctuating vision items (summed responses to questions 3a and 3b only)
  • CLDEQ-8 total score
    • Time Frame: 3 months
    • Change from baseline to month 3 in CLDEQ-8 total score

Participating in This Clinical Trial

Inclusion Criteria

Evidence of meibomian gland obstruction (based on a meibomian gland secretion (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes. A history of wearing soft contact lenses for at least 6 months. Screening CLDEQ-8 score >12 Exclusion Criteria:

Active ocular infection (bacterial, viral, or fungal). Participant is unlikely to follow study instructions or to complete all required study visit(s) or has a condition or situation that in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study. Participant is an employee at the investigational site or is related to any member of the study staff. Participation in another clinical trial involving a therapeutic drug or device within the past 30 days

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azura Ophthalmics
  • Collaborator
    • Avania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Charles Bosworth, 17145598435, charles.bosworth@azuraophthalmics.com

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