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

NCT02848222 | Completed Results

• 1 other identifier: BR1016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Discomfort; Dry Eye Disease; Meibomian Gland Dysfunction

Keywords

contact lens discomfort; dry eye disease; meibomian gland dysfunction; Bruder mask

Outcome Measures

Primary Outcomes (1)

• Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)

  Baseline through 1 month

Study Arms (3)

Twice Daily Application of Bruder compress

EXPERIMENTAL

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

Once Daily Application of Bruder compress

EXPERIMENTAL

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

Device: Bruder Moist Heat Compress

Twice Daily Application of warm washcloth

SHAM COMPARATOR

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

Interventions

Bruder Moist Heat Compress DEVICE

Also known as: Bruder mask

Once Daily Application of Bruder compress; Twice Daily Application of Bruder compress

Washcloth OTHER

Twice Daily Application of warm washcloth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Bruder Healthcare Company: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35226, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Results Point of Contact

• Title: Dr Jason Nichols
• Organization: University of Alabama at Birmingham

jjn@uab.edu

205-975-3497

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 17, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-05

Locations

US (1)