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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02848222
Other study ID # BR1016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date December 2017

Study information

Verified date May 2018
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Bruder Moist Heat Compress

Other:
Washcloth


Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Bruder Healthcare Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) Baseline through 1 month
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