Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers

Conditions
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Contact Lens Discomfort, Dry Eye Disease, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Bruder Moist Heat Compress
* Other: Washcloth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twice Daily Application of Bruder compress<br>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 | Device: Bruder Moist Heat Compress<br> <br> * Other names: Bruder mask;|
| Experimental: Once Daily Application of Bruder compress<br>Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal | Device: Bruder Moist Heat Compress<br> <br> * Other names: Bruder mask;|
| Sham Comparator: Twice Daily Application of warm washcloth<br>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 | Other: Washcloth<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) |  | Baseline through 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bruder mask, contact lens discomfort, dry eye disease, meibomian gland dysfunction