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

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Contact Lens Discomfort Dry Eye Disease Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Bruder Moist Heat Compress

Intervention Type DEVICE

Once Daily Application of Bruder compress

Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal

Group Type EXPERIMENTAL

Bruder Moist Heat Compress

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Washcloth

Intervention Type OTHER

Interventions

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Bruder Moist Heat Compress

Intervention Type DEVICE

Washcloth

Intervention Type OTHER

Other Intervention Names

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Bruder mask

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No