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

Primary Purpose

Contact Lens Discomfort, Dry Eye Disease, Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bruder Moist Heat Compress
Washcloth
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Lens Discomfort focused on measuring contact lens discomfort, dry eye disease, meibomian gland dysfunction, Bruder mask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Twice Daily Application of Bruder compress

Once Daily Application of Bruder compress

Twice Daily Application of warm washcloth

Arm 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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 26, 2016
Last Updated
May 14, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
Bruder Healthcare Company
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1. Study Identification

Unique Protocol Identification Number
NCT02848222
Brief Title
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Official Title
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Bruder Healthcare Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Discomfort, Dry Eye Disease, Meibomian Gland Dysfunction
Keywords
contact lens discomfort, dry eye disease, meibomian gland dysfunction, Bruder mask

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twice Daily Application of Bruder compress
Arm Type
Experimental
Arm 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
Arm Title
Once Daily Application of Bruder compress
Arm Type
Experimental
Arm Description
Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
Arm Title
Twice Daily Application of warm washcloth
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Bruder Moist Heat Compress
Other Intervention Name(s)
Bruder mask
Intervention Type
Other
Intervention Name(s)
Washcloth
Primary Outcome Measure Information:
Title
Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
Time Frame
Baseline through 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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