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

Azura Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Contact Lens Discomfort

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05548491

AZ202201

Details and patient eligibility

About

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 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups, including a placebo group

AZR-MD-001 1.0%

Experimental group

Description:

AZR-MD-001 ointment/semi-solid drug (1.0%)

Treatment:

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

AZR-MD-001 vehicle

Placebo Comparator group

Description:

AZR-MD-001 vehicle

Treatment:

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