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

Contact Lens Discomfort Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548491
• Other study ID #: AZ202201
• Status: Completed
• Phase: Phase 2
• Start date: November 10, 2022
• Est. completion date: October 13, 2023

Study information

• Verified date: October 2023
• Source: Azura Ophthalmics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contact Lens Discomfort

Intervention

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

Locations

Country	Name	City	State
Australia	University of New South Wales, School of Optometry and Vision Science	Sydney	New South Wales
Australia	Ophthalmic Trials Australia	Teneriffe	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Azura Ophthalmics	Avania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian Glands Yielding Liquid Secretion (MGYLS) Yielding Liquid Secretion (MGYLS)	Change from baseline to month 3 in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS)	3 months
Primary	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) fluctuating vision	Change from baseline to month 3 in CLDEQ-8 fluctuating vision items. Scores can range from 0 (normal) to 9 (impacted vision).; (summed responses to questions 3a and 3b only)	3 months
Primary	Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score	Change from baseline to month 3 in CLDEQ-8 total score. Scores can range from 0 (normal) to 37 (Impacted Contact Use).	3 months