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Artificial Tears
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
Phase 4
Waitlist Available
Led By Yujia Zhou
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial is testing eye drops with a substance called CMC to see if it changes the bacteria in the eyes. Carboxymethylcellulose (CMC) is a common ingredient in artificial tears, used to improve eye hydration and reduce surface friction. The study involves people who use artificial tears and aims to understand how these drops might affect eye health.
Eligible Conditions
- Dry Eye Syndrome
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Beta Diversity (Unweighted UniFrac)
Beta Diversity (Weighted UniFrac)
Species Diversity
+1 moreSecondary study objectives
Artificial Tear Use
Ocular Surface Disease Index Score
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carboxymethylcellulose (CMC) Artificial TearsExperimental Treatment1 Intervention
Refresh brand artificial tears containing 0.5% carboxymethylcellulose will be self-administered three times a day in each eye by the participants for 1 week in the experimental arm.
Group II: Preservative-free, CMC-free Artificial TearsPlacebo Group1 Intervention
Systane brand artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be self-administered three times a day in each eye by the participants for 1 week in the control arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboxymethylcellulose (CMC) Artificial Tears
2022
Completed Phase 4
~80
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,404 Previous Clinical Trials
766,250 Total Patients Enrolled
Yujia ZhouPrincipal InvestigatorUniversity of Florida