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

TearScience

Status: Completed

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Device: Warm Compress Therapy + Lid Scrub; Device: LipiFlow System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521507

LF-004

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

LipiFlow System

Experimental group

Description:

Treatment with LipiFlow System at randomization in Stage 1 of study

Treatment:

Device: LipiFlow System

Warm Compress and Lid Hygiene

Active Comparator group

Description:

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

Treatment:

Device: LipiFlow System

Device: Warm Compress Therapy + Lid Scrub