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Artificial Tears
Carboxymethylcellulose (CMC) Artificial Tears for Dry Eye Syndrome
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
Study Summary
Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to modify the gut microbiome. The study is examining its effects on the eye microbiome, which may have implications on ocular disease and artificial tear choice. The study will administer artificial tears containing CMC to the treatment group and artificial tears without CMC to the control group. Surveys and conjunctival swabs will be collected before and after treatment for bacterial genome sequencing and analyzed by R statistical packages.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beta Diversity (Unweighted UniFrac)
Beta Diversity (Weighted UniFrac)
Species Diversity
+1 moreSecondary outcome measures
Artificial Tear Use
Ocular Surface Disease Index Score
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
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,566 Total Patients Enrolled
Yujia ZhouPrincipal InvestigatorUniversity of Florida
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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