Status:
COMPLETED
Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
Lead Sponsor:
TearScience, Inc.
Conditions:
Meibomian Gland Dysfunction
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a st...
Eligibility Criteria
Inclusion
- At least 18 years old
- Tear film assessment that qualifies in both eyes
- Evidence of meibomian gland dysfunction and dry eye in both eyes
- Willingness to comply with study protocol
Exclusion
- Systemic disease condition or medication that causes dry eye
- Use of other treatments for MGD or dry eye
- Ocular surgery, trauma, herpes infection, punctal plug insertion or punctal occlusion within past 3 months
- Active eye infection
- Active eye inflammation or recurrent inflammation within past 3 months
- Moderate to severe allergic conjunctivitis
- Severe eyelid inflammation
- Eyelid abnormality that affects lid function
- Ocular surface abnormality that may compromise corneal integrity
- Pregnant or nursing women
- Participation in another ophthalmic clinical trial within past 30 days
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01521507
Start Date
January 1 2012
End Date
January 1 2014
Last Update
February 23 2015
Active Locations (9)
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1
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
2
Harvard Eye Associates
Laguna Hills, California, United States, 92653
3
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
4
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169