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

Completed · Not applicable

Conditions studied: Meibomian Gland Dysfunction, Dry Eye

In brief

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.

Key facts

Study ID

NCT01521507

Run by

TearScience, Inc.

People needed

200

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McDonald Eye Associates — Fayetteville, Arkansas, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Center for Excellence in Eye Care — Miami, Florida, United States
• Chicago Cornea Consultants, Ltd. — Hoffman Estates, Illinois, United States
• Jackson Eye — Lake Villa, Illinois, United States
• Cincinnati Eye Institute - Northern Kentucky — Edgewood, Kentucky, United States
• Charles River Eye Associates — Winchester, Massachusetts, United States
• Associated Eye Care — Stillwater, Minnesota, United States
• Ophthalmology Consultants, Ltd. — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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