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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meibomian Gland Dysfunction Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LipiFlow System

Treatment with LipiFlow System at randomization in Stage 1 of study

Group Type EXPERIMENTAL

LipiFlow System

Intervention Type DEVICE

In-office device treatment for meibomian gland dysfunction by a physician

Warm Compress and Lid Hygiene

Control group receiving warm compress therapy and lid hygiene at randomization in Stage 1 of study and crossover LipiFlow System treatment in Stage 2 of study

Group Type ACTIVE_COMPARATOR

LipiFlow System

Intervention Type DEVICE

In-office device treatment for meibomian gland dysfunction by a physician

Warm Compress Therapy + Lid Scrub

Intervention Type DEVICE

At-home daily warm compress therapy and lid hygiene

Interventions

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LipiFlow System

In-office device treatment for meibomian gland dysfunction by a physician

Intervention Type DEVICE

Warm Compress Therapy + Lid Scrub

At-home daily warm compress therapy and lid hygiene

Intervention Type DEVICE

Other Intervention Names

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EyeGiene Warm Compress Therapy OCuSOFT Lid Scrub

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No