Dry Eye SyndromesPhase 4NCT05292755
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
A Phase 4 study testing Carboxymethylcellulose (CMC) Artificial Tears in people with Dry Eye Syndromes, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Carboxymethylcellulose (CMC) Artificial Tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 1 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Florida Oaks Eye Center
Gainesville, Florida, 32605
About this study
Official title: Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study
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
- Being tested
- Carboxymethylcellulose (CMC) Artificial Tears, Preservative-free, CMC-free Artificial Tears (control)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboxymethylcellulose (CMC) Artificial TearsDrug
Also called Refresh Plus
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 (control)Drug
Also called Systane Ultra PF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Preservative-free, CMC-free Artificial Tears (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Secondary outcomes (2)
Ocular Surface Disease Index Score
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 conducted a survey before and after intervention, and the difference will be used as the outcome measure. The OSDI ranges from 0 to 48, and a higher score indicates greater ocular surface dryness. If reporting the difference, a more negative change in OSDI indicates greater improvement in dry eye symptoms. Pairwise Wilcoxon signed rank tests were used to compare changes in OSDI between intervention groups at a two-tailed 95% confidence interval.
Measured: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Artificial Tear Use
Patients will be asked 1 week after intervention how many times they administered eye drops each day. This measures compliance with intervention, ranging from zero drops per day to infinite drops per day. If a patient is perfectly compliant, the number of drops should be 3. Mann-U-Whitney tests were used to compare compliance between intervention groups at a two-tailed 95% confidence interval.
Measured: Assessed at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start22 Apr 2022
- Primary completion30 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yujia Zhou, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292755
- Sponsor's protocol ID
- IRB202200427 -A
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2022
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37555738
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome: a Randomized, Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT05292755
- Acronym / sponsor ID
- IRB202200427 -A
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboxymethylcellulose (CMC) Artificial Tears | Experimental | Drug: Carboxymethylcellulose (CMC) Artificial TearsRefresh 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. |
| Preservative-free, CMC-free Artificial Tears | Placebo comparator | Drug: Preservative-free, CMC-free Artificial Tears (control)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboxymethylcellulose (CMC) Artificial TearsAlso: Refresh PlusA pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group. | Drug | Carboxymethylcellulose (CMC) Artificial Tears |
| Preservative-free, CMC-free Artificial Tears (control)Also: Systane Ultra PFA 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. | Drug | Preservative-free, CMC-free Artificial Tears |
Primary outcome
Species Richness
Time frame: Assessed at day 1 and day 7, day 7 reported.
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.
Species Diversity
Time frame: Assessed at day 1 and day 7, day 7 reported.
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.
Beta Diversity (Unweighted UniFrac)
Time frame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
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.
Beta Diversity (Weighted UniFrac)
Time frame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
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.
2 secondary outcomes
Ocular Surface Disease Index Score
Time frame: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.
Artificial Tear Use
Time frame: Assessed at day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37555738Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yujia Zhou principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carboxymethylcellulose (CMC) Artificial Tears in people with Dry Eye Syndromes, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Species Richness (time frame: Assessed at day 1 and day 7, day 7 reported.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.