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: February 4, 2015
Last verified: February 2015
  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:
  • Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months [ Time Frame: Baseline and 3 Months ] [ Designated as safety issue: No ]
    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.

  • Stage 2 Mean Total Meibomian Gland Score at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months [ Time Frame: Baseline, 3 Months ] [ Designated as safety issue: No ]
    Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.

  • Stage 2 Mean Total OSDI Score at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.


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
Results First Received: February 4, 2015
Last Updated: February 4, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2015