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)
Verified date | October 2023 |
Source | Azura Ophthalmics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Azura Ophthalmics | Avania |
Australia,
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 |
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