Clinical trial NCT05548491: Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD)
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contact Lens Discomfort
Lead sponsor: Azura Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-09-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)
timeFrame: 3 months
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision
timeFrame: 3 months
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of New South Wales, School of Optometry and Vision Science
state: New South Wales
city: Teneriffe
country: Australia
facility: Ophthalmic Trials Australia
state: Queensland
Study officials:
References: