Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

NCT05292755 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB202200427 -A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Species Richness

  Sampled 16S rRNA sequences were organized into 'operational taxonomic units' (OTUs) at a 97% sequence similarity threshold, and a phylogenetic tree was constructed from sampled OTUs using the QIIME2 bioinformatics platform. Faith's phylogenetic diversity was used as a measure of species richness, calculated as the sum of all phylogenetic tree branch lengths using the QIIME2 faith\_pd plugin. The units for this measure are the number of nucleotide substitutions (phylogenetic distance, i.e. length) per branch, which is a scale measure from zero to infinity. Zero indicates a completely homogenous sample, and higher scores indicate greater species richness.

  Assessed at day 1 and day 7, day 7 reported.

• Species Diversity

  Sampled 16S rRNA sequences were organized into 'operational taxonomic units' (OTUs) at a 97% sequence similarity threshold. Shannon's diversity index was used as a measure of species diversity, calculated as the sum of -p/ln(p), where p is the proportion of the sample made up of each OTU using the QIIME2 shannon\_pd plugin. This measure is a unitless scale proportion ranging from zero to infinity. Zero indicates a completely homogenous sample, and higher scores indicate greater species diversity.

  Assessed at day 1 and day 7, day 7 reported.

• Beta Diversity (Unweighted UniFrac)

  Sampled 16S rRNA sequences were organized into 'operational taxonomic units' (OTUs) at a 97% sequence similarity threshold, and a phylogenetic tree was constructed from sampled OTUs using the QIIME2 bioinformatics platform. Unweighted UniFrac distances were calculated as the number of shared nucleotide substitutions between two samples divided by the number of shared nucleotide substitutions among all samples using the QIIME2 unifrac plugin. The unweighted UniFrac is a unitless scale proportion ranging from zero to one. Greater UniFrac distances indicate greater beta diversity.

  Assessed at day 1 and day 7, difference between day 1 and day 7 reported.

• Beta Diversity (Weighted UniFrac)

  Sampled 16S rRNA sequences were organized into 'operational taxonomic units' (OTUs) at a 97% sequence similarity threshold, and a phylogenetic tree was constructed from sampled OTUs using the QIIME2 bioinformatics platform. Weighted UniFrac distances were calculated as the number of shared nucleotide substitutions between two samples divided by the number of shared nucleotide substitutions among all samples using the QIIME2 unifrac plugin, with samples weighted by abundance of species. The weighted UniFrac (weighted by number of duplicate OTUs) is a unitless scale proportion ranging from zero to infinity. Greater UniFrac distances indicate greater beta diversity.

  Assessed at day 1 and day 7, difference between day 1 and day 7 reported.

Secondary Outcomes (2)

• Ocular Surface Disease Index Score

  Assessed at day 1 and day 7, difference between day 1 and day 7 reported.

• Artificial Tear Use

  Assessed at day 7

Study Arms (2)

Carboxymethylcellulose (CMC) Artificial Tears

EXPERIMENTAL

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.

Drug: Carboxymethylcellulose (CMC) Artificial Tears

Preservative-free, CMC-free Artificial Tears

PLACEBO COMPARATOR

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.

Drug: Preservative-free, CMC-free Artificial Tears (control)

Interventions

Carboxymethylcellulose (CMC) Artificial Tears DRUG

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

Also known as: Refresh Plus

Carboxymethylcellulose (CMC) Artificial Tears

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.

Also known as: Systane Ultra PF

Preservative-free, CMC-free Artificial Tears

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.

You may not qualify if:

• Individuals with active eye infections or have prosthetic eyes.
• Are immunocompromised, or are diagnosed with autoimmune diseases or malignant neoplasms about the eye.
• Individuals who take immunomodulatory therapy, steroids, antibiotics, medicated eyedrops, or are already using CMC eyedrops within 1 week of the study will also be excluded.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Oaks Eye Center

Gainesville, Florida, 32605, United States

Location

Related Publications (1)

• 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.

  PMID: 37555738 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium; MCC protocol; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr. Yujia Zhou
• Organization: University of Florida

yzhou1996@ufl.edu

3053429166

Study Officials

• Yujia Zhou

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: April 22, 2022
• Primary Completion: May 30, 2022
• Study Completion: July 1, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)