Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

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.

Timeline

Start

2022-04-22

Primary completion

2022-05-30

Completion

2022-07-01

Outcome

Missed primary endpoint

registry analysis (other test); Carboxymethylcellulose (CMC) Artificial Tears vs Preservative-free, CMC-free Artificial Tears; p = 0.232; ANOVA NCT05292755 ↗

registry analysis (other test); Carboxymethylcellulose (CMC) Artificial Tears vs Preservative-free, CMC-free Artificial Tears; p = 0.224; ANOVA NCT05292755 ↗

registry analysis (other test); Carboxymethylcellulose (CMC) Artificial Tears vs Preservative-free, CMC-free Artificial Tears; p = 0.227; Repeated measures Mann-U-Whitney NCT05292755 ↗

paper Neither intervention affected Chao-1 richness (analysis of variance [ANOVA], P = 0.231) or Shannon's diversity index (ANOVA, P = 0.224). PMID 37555738 ↗

Publications

• Zhou Y, Sidhu GS, Whitlock JA, Abdelmalik B, Mayer Z, Li Y, Wang GP, Steigleman WA. Effects of Carboxymethylcellulose Artificial Tears on Ocular Surface Microbiome Diversity and Composition, A Randomized Controlled Trial. Transl Vis Sci Technol. 2023 Aug 1;12(8):5. doi: 10.1167/tvst.12.8.5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboxymethylcellulose	Other / unclassified	0.5 %	Other
Comparator	Polyethylene glycol 400	Unknown	0.4 %	Other
Comparator	Propylene Glycol	Small molecule	0.3 %	Other

Indications