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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT01521507
First received: January 26, 2012
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Meibomian Gland Dysfunction
Dry Eye
Device: LipiFlow System
Device: Warm Compress Therapy + Lid Scrub

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye

Resource links provided by NLM:


Further study details as provided by TearScience, Inc.:

Primary Outcome Measures:
  • Mean Change in Total Meibomian Gland Score from Baseline to 3 Months [ Time Frame: Baseline and 3 Months ] [ Designated as safety issue: No ]
  • Mean Change in Total Meibomian Gland Score from Baseline to 6 Months [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Mean Change in Total Meibomian Gland Score from Baseline to 12 Months [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change in Total OSDI Score from Baseline to 3 Months [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
  • Mean Change in Total OSDI Score from Baseline to 6 Months [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Mean Change in Total OSDI Score from Baseline to 12 Months [ Time Frame: Baseline, 12 Months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LipiFlow System
Treatment with LipiFlow System at randomization in Stage 1 of study
Device: LipiFlow System
In-office device treatment for meibomian gland dysfunction by a physician
Active Comparator: 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
Device: LipiFlow System
In-office device treatment for meibomian gland dysfunction by a physician
Device: Warm Compress Therapy + Lid Scrub
At-home daily warm compress therapy and lid hygiene
Other Names:
  • EyeGiene Warm Compress Therapy
  • OCuSOFT Lid Scrub

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521507

Locations
United States, Arkansas
McDonald Eye Associates
Fayetteville, Arkansas, United States, 72703
United States, California
Harvard Eye Associates
Laguna Hills, California, United States, 92653
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Illinois
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169
Jackson Eye
Lake Villa, Illinois, United States, 50046
United States, Kentucky
Cincinnati Eye Institute - Northern Kentucky
Edgewood, Kentucky, United States, 41017
United States, Massachusetts
Charles River Eye Associates
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Associated Eye Care
Stillwater, Minnesota, United States, 55082
United States, Missouri
Ophthalmology Consultants, Ltd.
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
TearScience, Inc.
Investigators
Study Director: Christy Stevens, O.D. TearScience, Inc.
  More Information

No publications provided

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01521507     History of Changes
Other Study ID Numbers: LF-004
Study First Received: January 26, 2012
Last Updated: March 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 22, 2014