Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Carboxymethylcellulose (CMC) Artificial Tears

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Refresh Plus Systane Ultra PF

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes