NCT05292755

Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Carboxymethylcellulose (CMC) Artificial Tears	A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.
DRUG	Preservative-free, CMC-free Artificial Tears (control)	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.

Timeline

• Start date: 2022-04-22
• Primary completion: 2022-05-30
• Completion: 2022-07-01
• First posted: 2022-03-23
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study