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Macrolide Antibiotic
Azithromycin for Meibomian Gland Dysfunction
Phase 4
Waitlist Available
Led By Thuy Doan, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months.
Awards & highlights
Summary
This trial will study whether azithromycin can treat dry eye syndrome caused by Meibomian gland dysfunction.
Eligible Conditions
- Neuropathic Eye Pain
- Dry Eye Syndrome
- Ocular Microbiome
- Depression and Anxiety
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ocular Surface Disease Index (OSDI) Questionnaire
Secondary study objectives
Eye
Eye
Human Microbiome
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: AzithromycinActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,562 Previous Clinical Trials
15,254,745 Total Patients Enrolled
Thuy Doan, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
697 Total Patients Enrolled
Julie Schallhorn, MD, MSPrincipal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the preservatives in the 0.1% dexamethasone eye drops.You have a history of heart rhythm problems or heart failure.You are currently taking medications that can affect your heart's rhythm.You are allergic or intolerant to taking azithromycin by mouth or using dexamethasone on your skin.You have very low tear production, measured by a specific test.You have an eye condition that causes inflammation on the surface of your eyes.You have an allergic condition that affects your eyes.You are taking more than 5mg of prednisone by mouth every day.You have used steroid eye drops in the last 30 days.You have used any eye drops for inflammation in the last 30 days.Your OSDI score is 20 or more.You have a condition called limbal stem cell deficiency.You have used oral or eye antibiotics in the last 90 days.You have noticeable eye discomfort along with a specific level of Meibomian gland disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Azithromycin
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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