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

NCT01521507 | Completed Results

• 1 other identifier: LF-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

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. 1.One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.
2. 2.Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.
3. 3.Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.

Conditions

Meibomian Gland Dysfunction; Dry Eye

Outcome Measures

Primary Outcomes (2)

• Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months

  To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.

  Baseline and 3 Months

• Stage 2 Mean Total Meibomian Gland Score at 12 Months

  To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.

  12 Months

Secondary Outcomes (2)

• Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months

  Baseline, 3 Months

• Stage 2 Mean Total OSDI Score at 12 Months

  12 Months

Study Arms (2)

LipiFlow System

EXPERIMENTAL

Treatment with LipiFlow System at randomization in Stage 1 of study

Device: LipiFlow System

Warm Compress and Lid Hygiene

ACTIVE COMPARATOR

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

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

Interventions

LipiFlow System DEVICE

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

LipiFlow System; Warm Compress and Lid Hygiene

Warm Compress Therapy + Lid Scrub DEVICE

At-home daily warm compress therapy and lid hygiene

Also known as: EyeGiene Warm Compress Therapy, OCuSOFT Lid Scrub

Warm Compress and Lid Hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• TearScience, Inc.: lead

Study Sites (9)

McDonald Eye Associates

Fayetteville, Arkansas, 72703, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Location

Jackson Eye

Lake Villa, Illinois, 50046, United States

Location

Cincinnati Eye Institute - Northern Kentucky

Edgewood, Kentucky, 41017, United States

Location

Charles River Eye Associates

Winchester, Massachusetts, 01890, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Ophthalmology Consultants, Ltd.

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Study Director
• Organization: TearScience, Inc.

cstevens@tearscience.com

919-467-4007

Study Officials

• Christy Stevens, O.D.

  TearScience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 23, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

US (9)