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

The University of Alabama at Birmingham

Status: Completed

Conditions: Contact Lens Discomfort; Meibomian Gland Dysfunction; Dry Eye Disease

Treatments: Other: Washcloth; Device: Bruder Moist Heat Compress

Study type: Interventional

Funder types: Other

Identifiers

NCT02848222

BR1016

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Twice Daily Application of Bruder compress

Experimental group

Description:

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

Treatment:

Device: Bruder Moist Heat Compress

Once Daily Application of Bruder compress

Experimental group

Description:

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

Treatment:

Device: Bruder Moist Heat Compress

Twice Daily Application of warm washcloth

Sham Comparator group

Description:

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

Treatment:

Other: Washcloth