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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05548491
Other study ID # AZ202201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT05416528 - Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)
Completed NCT03311204 - The Effect of Eyelid Margin Debridement on Contact Lens Discomfort N/A
Active, not recruiting NCT03652337 - Meibomian Gland Dysfunction Management N/A
Not yet recruiting NCT05801991 - Neurolens and Contact Lens Discomfort N/A
Completed NCT03994406 - Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel Phase 2
Completed NCT02848222 - Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers N/A
Completed NCT03686878 - Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness Phase 4