Meibomian Gland DysfunctionNCT01521507

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

A study testing LipiFlow System and Warm Compress Therapy + Lid Scrub in people with Meibomian Gland Dysfunction and Dry Eye, run by TearScience, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Meibomian Gland Dysfunction, Dry Eye
What is being tested?: LipiFlow System and Warm Compress Therapy + Lid Scrub
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 9 sitesUnited States
Study dates: Jan 2012to Jan 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Cincinnati Eye Institute - Northern Kentucky
Edgewood, Kentucky, 41017
McDonald Eye Associates
Fayetteville, Arkansas, 72703
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169
Harvard Eye Associates
Laguna Hills, California, 92653
Jackson Eye
Lake Villa, Illinois, 50046
Center for Excellence in Eye Care
Miami, Florida, 33176
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131
Associated Eye Care
Stillwater, Minnesota, 55082
Charles River Eye Associates
Winchester, Massachusetts, 01890

Other trials in United States

About this study

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.

One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.
Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.
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
Being tested: LipiFlow System, Warm Compress Therapy + Lid Scrub
Medical subject headings: Meibomian Gland Dysfunction, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LipiFlow SystemDevice
In-office device treatment for meibomian gland dysfunction by a physician
Warm Compress Therapy + Lid ScrubDevice
Also called EyeGiene Warm Compress Therapy, OCuSOFT Lid Scrub
At-home daily warm compress therapy and lid hygiene

Study groups in NCT01521507
Study group	Role	What they receive
LipiFlow System	Experimental	Treatment with LipiFlow System at randomization in Stage 1 of study Receives: 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 Receives: Device: LipiFlow System; Device: Warm Compress Therapy + Lid Scrub

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 Months

Secondary outcomes (2)

Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months
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.
Measured: Baseline, 3 Months
Stage 2 Mean Total OSDI Score at 12 Months
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.
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jan 2014

First posted30 Jan 2012 (estimated)
Study startJan 2012
Primary completionNov 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01521507
Sponsor's protocol ID: LF-004
Status last verified: Feb 2015
First submitted: 26 Jan 2012
Last updated: 23 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

All Meibomian Gland Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
ClinicalTrials.gov ID: NCT01521507
Acronym / sponsor ID: LF-004
Conditions: Meibomian Gland Dysfunction, Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: TearScience, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Nov 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 30 Jan 2012 (estimated)
Results: Posted 23 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LipiFlow System	Experimental	Device: LipiFlow SystemTreatment with LipiFlow System at randomization in Stage 1 of study
Warm Compress and Lid Hygiene	Active comparator	Device: LipiFlow System, Device: Warm Compress Therapy + Lid ScrubControl 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LipiFlow SystemIn-office device treatment for meibomian gland dysfunction by a physician	Device	LipiFlow System, Warm Compress and Lid Hygiene
Warm Compress Therapy + Lid ScrubAlso: EyeGiene Warm Compress Therapy, OCuSOFT Lid ScrubAt-home daily warm compress therapy and lid hygiene	Device	Warm Compress and Lid Hygiene

Primary outcome

Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
Time frame: Baseline and 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.
Stage 2 Mean Total Meibomian Gland Score at 12 Months
Time frame: 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.

2 secondary outcomes

Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months
Time frame: Baseline, 3 Months
Stage 2 Mean Total OSDI Score at 12 Months
Time frame: 12 Months

Results and safety

Results posted to the registry on 23 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LipiFlow Treatment	101	98
Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment	99	94

Primary outcome: Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months

Time frame: Baseline and 3 Months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	LipiFlow Treatment n = 98	Warm Compress & Lid Hygiene n = 94
Value	11.6 (10.2 to 13.0)	4.5 (3.4 to 5.6)

LipiFlow Treatment vs Warm Compress & Lid Hygiene: p <0.0001, z-statistic
LipiFlow Treatment vs Warm Compress & Lid Hygiene: p = 0.0020, Mixed Models Analysis

Population analysed: Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).

Primary outcome: Stage 2 Mean Total Meibomian Gland Score at 12 Months

Time frame: 12 Months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	LipiFlow Arm: One LipiFlow Treatment Subgroup n = 81	LipiFlow Arm: Combination Treatment Subgroup n = 11	Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup n = 82	Warm Compress/Hygiene Arm: Combination Treatment Subgroup n = 9
Value	17.3 (15.8 to 18.7)	17.9 (13.1 to 22.7)	18.4 (16.7 to 20.1)	17.4 (13.2 to 21.6)

LipiFlow Arm: One LipiFlow Treatment Subgroup vs LipiFlow Arm: Combination Treatment Subgroup vs Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup vs Warm Compress/Hygiene Arm: Combination Treatment Subgroup: p = 0.9098, Mixed Models Analysis

Population analysed: Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n\<5) for meaningful analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LipiFlow Treatment	0 of 101 (0%)	6 of 101 (5.9%)	Not reported
Warm Compress & Lid Hygiene	0 of 99 (0%)	7 of 99 (7.1%)	Not reported
Crossover LipiFlow Treatment	0 of 94 (0%)	4 of 94 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meibomian Gland Dysfunction

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christy Stevens, O.D. study director

TearScience, Inc.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LipiFlow System and Warm Compress Therapy + Lid Scrub in people with Meibomian Gland Dysfunction and Dry Eye, run by TearScience, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months (time frame: Baseline and 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01521507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.