Dry Eye Disease Clinical Trial
Official title:
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
| 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 |
| Verified date | May 2018 |
| Source | University of Alabama at Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham | Bruder Healthcare Company |
United States,
| 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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