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

Not Applicable

Completed

• Conditions: Contact Lens Discomfort; Meibomian Gland Dysfunction; Dry Eye Disease
• Interventions: Device: Bruder Moist Heat Compress; Other: Washcloth

• Registration Number: NCT02848222
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2018-03-06
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Results First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twice Daily Application of Bruder compress	Bruder Moist Heat 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
Once Daily Application of Bruder compress	Bruder Moist Heat Compress	Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
Twice Daily Application of warm washcloth	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

Primary Outcome Measures

Name	Time	Method
Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)	Baseline through 1 month

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States