Contact Lens Discomfort, Dry Eye Disease, Meibomian Gland Dysfunction
Conditions
Keywords
contact lens discomfort, dry eye disease, meibomian gland dysfunction, Bruder mask
Brief summary
The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.
Interventions
DEVICEBruder Moist Heat Compress
OTHERWashcloth
Sponsors
Bruder Healthcare Company
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Provide informed consent and authorization to disclose protected health information * Have habitual contact lens corrected visual acuity in each eye of at least 20/30 * Willing to comply with protocol * Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 days a week on average over at least a 30 day period before enrollment
Exclusion criteria
* Have any uncontrolled systemic disease that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease * Pregnant by self-report * Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | Baseline through 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Twice Daily Application of Bruder Compress Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal | 17 |
| Group 2: Once Daily Application of Bruder Compress Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal | 17 |
| Group 3: Twice Daily Application of Warm Washcloth Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Total | Group 1: Twice Daily Application of Bruder Compress | Group 2: Once Daily Application of Bruder Compress | Group 3: Twice Daily Application of Warm Washcloth |
|---|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 8 | 32 years STANDARD_DEVIATION 12 | 36 years STANDARD_DEVIATION 11 |
| Comfortable Contact Lens Wear Time | 7.3 hours per day STANDARD_DEVIATION 3.4 | 7.8 hours per day STANDARD_DEVIATION 3 | 8.0 hours per day STANDARD_DEVIATION 3.9 | 5.9 hours per day STANDARD_DEVIATION 3.2 |
| Race/Ethnicity, Customized Race African American | 18 Participants | 5 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Caucasian | 26 Participants | 10 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 51 participants | 17 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 50 Participants | 16 Participants | 17 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 25 | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 25 | 0 / 18 | 0 / 17 |
Outcome results
Primary
Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
Time frame: Baseline through 1 month
Population: In Gr1, 25 subjects were randomized, 18 subjects completed, 7 discontinued early and 1 subject's data was not used due to poor compliance resulting in 17 subjects analyzed. In Gr2, 18 subjects were randomized and 17 completed. In Gr3, 17 subjects were randomized and completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Twice Daily Application of Bruder Compress | Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | 9.2 hours per day | Standard Deviation 2.8 |
| Group 2: Once Daily Application of Bruder Compress | Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | 8.5 hours per day | Standard Deviation 3.6 |
| Group 3: Twice Daily Application of Warm Washcloth | Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | 7.1 hours per day | Standard Deviation 2.8 |
p-value: 0.02ANOVA