Clinical trial NCT01521507: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
Official title: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
timeFrame: Baseline and 3 Months
measure: Stage 2 Mean Total Meibomian Gland Score at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months
timeFrame: Baseline, 3 Months
measure: Stage 2 Mean Total OSDI Score at 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: McDonald Eye Associates
state: Arkansas
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Lake Villa
country: United States
facility: Jackson Eye
state: Illinois
city: Edgewood
country: United States
facility: Cincinnati Eye Institute - Northern Kentucky
state: Kentucky
city: Winchester
country: United States
facility: Charles River Eye Associates
state: Massachusetts
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: St. Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
Study officials:
affiliation: TearScience, Inc.
name: Christy Stevens, O.D.
role: STUDY_DIRECTOR
References: