CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Carboxymethylcellulose (CMC) Artificial Tears +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05292755
NCT05292755Phase 4Completed
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Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study

University of Florida·interventional·Posted Mar 23, 2022·Updated Apr 20, 2023

In Brief

A Phase 4 clinical trial evaluating Carboxymethylcellulose (CMC) Artificial Tears and Preservative-free, CMC-free Artificial Tears (control) for Dry Eye Syndromes. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 23, 2022
Enrollment StartApr 22, 2022
Primary CompletionMay 30, 2022
Study CompletionJul 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.3 years ago

Interventions

Carboxymethylcellulose (CMC) Artificial Tearsdrug

A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.

Preservative-free, CMC-free Artificial Tears (control)drug

A pack of 21 vials of artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be given to subjects in the control group.