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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

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 below

Timeline

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at day 1 and day 7, difference between day 1 and day 7 reported. for reporting.

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 more

Secondary 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

0 / 1Eligibility criteria met