Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT05292755
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 32.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Carboxymethylcellulose (CMC) Artificial Tears; Drug: Preservative-free, CMC-free Artificial Tears (control)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study
• Actual Study Start Date: Apr 22, 2022
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboxymethylcellulose (CMC) Artificial Tears 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; A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.; Other Names: Refresh Plus
Placebo Comparator: Preservative-free, CMC-free Artificial Tears 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); 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.; Other Names: Systane Ultra PF

Outcome Measures

Primary Outcome Measures

1. Species Richness [1 week after intervention start]

   The standard pipeline for bacterial rRNA 16S microbiome analysis starts by clustering rRNA sequences within a percent sequence similarity threshold (typically 97%) into 'operational taxonomic units' (OTUs). The number of OTUs, or species richness, is one measure of microbiome diversity within a sample, or alpha-diversity. We will examine changes in richness for individuals in each treatment group.

2. Shannon Diversity Index [1 week after intervention start]

   The Shannon diversity index quantifies the uncertainty of predicting the presence of species within a microbiome sample. The Shannon diversity index is one measure of microbiome diversity within a sample, or alpha-diversity. We will examine changes in diversity for individuals in each treatment group.

3. Bray Curtis Dissimilarity [1 week after intervention start]

   Bray-Curtis dissimilarity is a measure of compositional dissimilarity between two different samples, and is one measure of microbiome diversity between samples, or beta-diversity. We will calculate the dissimilarity between each treatment group, and between samples collected before and after intervention.

Secondary Outcome Measures

1. Ocular Surface Disease Index Score [1 week after intervention start]

   The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Participants will conduct a survey before and after intervention.

2. Artificial Tear Use [1 week after intervention start]

   Patients will be asked 1 week after intervention how many times they administered eye drops each day. This measures compliance with intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida Oaks Eye Center	Gainesville	Florida	United States	32605

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Yujia Zhou, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT05292755
• Other Study ID Numbers: IRB202200427 -A
• First Posted: Mar 23, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dry Eye Syndromes; Carboxymethylcellulose Sodium; Lubricant Eye Drops

Study Results

No Results Posted as of Jul 22, 2022