Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2012
End Date:August 2013
Contact:Christy Stevens, OD
Email:CStevens@tearscience.com
Phone:919-459-4815

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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 standardized daily warm compress and eyelid hygiene control therapy
over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with
other MGD and dry eye treatments over a duration of up to 12 Months.

This is a post-market, non-significant risk, prospective and multi-center clinical trial
divided into two stages. The first stage from enrollment to 3 Months is an open-label,
randomized controlled design to compare the effectiveness of a single LipiFlow® System
treatment to a standardized daily warm compress and eyelid hygiene Control therapy with
Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage,
occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness
of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration
of up to 12 Months. Subjects are entered into the following subgroups based on the
subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria
for additional treatment.

1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.

2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.

3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed
by other MGD or dry eye treatment, as prescribed by the physician.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
10
sites
Fayetteville, Arkansas 72703
233
mi
from
Fayetteville, AR
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722
mi
from
Edgewood, KY
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Hoffman Estates, Illinois 60169
593
mi
from
Hoffman Estates, IL
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Laguna Hills, California 92653
1150
mi
from
Laguna Hills, CA
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Lake Villa, Illinois 50046
606
mi
from
Lake Villa, IL
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Miami, Florida 33176
1319
mi
from
Miami, FL
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Mt. Pleasant, South Carolina 29464
1066
mi
from
Mt. Pleasant, SC
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St. Louis, Missouri 63131
418
mi
from
St. Louis, MO
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Stillwater, Minnesota 55082
567
mi
from
Stillwater, MN
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Winchester, Massachusetts 01890
1440
mi
from
Winchester, MA
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