Trial Outcomes & Findings for Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome (NCT NCT05292755)
NCT ID: NCT05292755
Last Updated: 2023-04-20
Results Overview
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.
COMPLETED
PHASE4
80 participants
Assessed at day 1 and day 7, day 7 reported.
2023-04-20
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
35
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=40 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=40 Participants
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.
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 17.4 • n=40 Participants
|
40.2 years
STANDARD_DEVIATION 13.8 • n=40 Participants
|
40.6 years
STANDARD_DEVIATION 15.6 • n=80 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=40 Participants
|
28 Participants
n=40 Participants
|
55 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=40 Participants
|
12 Participants
n=40 Participants
|
25 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Contact lens use
|
9 Participants
n=40 Participants
|
10 Participants
n=40 Participants
|
19 Participants
n=80 Participants
|
|
Ocular surgery history
|
7 Participants
n=40 Participants
|
10 Participants
n=40 Participants
|
17 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Species Richness
|
11.0 units on a scale
Standard Deviation 2.1
|
11.1 units on a scale
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Species Diversity
|
3.9 score on a scale
Standard Deviation 1.1
|
4.1 score on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Beta Diversity (Unweighted UniFrac)
|
0.482 score on a scale
Interval 0.388 to 0.574
|
0.529 score on a scale
Interval 0.417 to 0.618
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Beta Diversity (Weighted UniFrac)
|
0.584 score on a scale
Interval 0.416 to 0.839
|
0.593 score on a scale
Interval 0.468 to 0.797
|
SECONDARY outcome
Timeframe: Assessed at day 1 and day 7, difference between day 1 and day 7 reported.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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Ocular Surface Disease Index Score
|
-1 score on a scale
Interval -5.5 to 0.0
|
-2 score on a scale
Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: Assessed at day 7Patients 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.
Outcome measures
| Measure |
Carboxymethylcellulose (CMC) Artificial Tears
n=35 Participants
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.
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.
|
Preservative-free, CMC-free Artificial Tears
n=31 Participants
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.
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.
|
|---|---|---|
|
Artificial Tear Use
|
2.86 eyedrops per day
Standard Deviation 0.81
|
2.16 eyedrops per day
Standard Deviation 0.82
|
Adverse Events
Carboxymethylcellulose (CMC) Artificial Tears
Preservative-free, CMC-free Artificial Tears
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place