Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

University of Florida

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05292755

IRB202200427 -A

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Carboxymethylcellulose (CMC) Artificial Tears

Experimental group

Description:

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.

Treatment:

Drug: Carboxymethylcellulose (CMC) Artificial Tears

Preservative-free, CMC-free Artificial Tears

Placebo Comparator group

Description:

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.

Treatment:

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