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 |
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
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