Meibomian GlandsNCT03226769

Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease

A study testing TrueTear™ and Thermalon Dry Eye Compress in people with Meibomian Glands and Dry Eye Syndromes, run by Allergan at 1 site 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

This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD). Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Meibomian Glands, Dry Eye Syndromes
What is being tested?: TrueTear™ and Thermalon Dry Eye Compress
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2017to 12 Dec 2017
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.
Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.

Who cannot join

Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.
History of nasal or sinus surgery.
Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.
Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.

Trial locations and contacts

1 site in 1 country.

United States1 site

Andover Eye Associates
Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease

This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).

Conditions: Meibomian Glands, Dry Eye Syndromes
Being tested: TrueTear™, Thermalon Dry Eye Compress
Medical subject headings: Dry Eye Syndromes

What participants receive

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

TrueTear™Device
Intranasal application of TrueTear™ device for approximately 8 minutes at Day 0, for approximately 3 minutes at Day 7 and then daily use of TrueTear™ per participant guide.
Thermalon Dry Eye CompressDevice
Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.

Study groups in NCT03226769
Study group	Role	What they receive
Thermalon	Active comparator	Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions. Receives: Device: Thermalon Dry Eye Compress
TrueTear™	Experimental	Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide. Receives: Device: TrueTear™

What is being measured

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

Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 0) to Day 30
Change From Baseline in MGD Symptoms Questionnaire Score
MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. A negative change from baseline indicates improvement.
Measured: Baseline (Day 0) to Day 30

Timeline

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

26 Jul 201712 Dec 2017

First posted24 Jul 2017
Study start26 Jul 2017
Primary completion12 Dec 2017
Study completion12 Dec 2017

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 GlandsStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03226769
Sponsor's protocol ID: OCUN-023
Status last verified: Oct 2020
First submitted: 20 Jul 2017
Last updated: 30 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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 Glands trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease
ClinicalTrials.gov ID: NCT03226769
Acronym / sponsor ID: OCUN-023
Conditions: Meibomian Glands, Dry Eye Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 26 Jul 2017 (actual)
Primary completion: 12 Dec 2017 (actual)
Study completion: 12 Dec 2017 (actual)
First posted: 24 Jul 2017 (actual)
Results: Posted 30 Oct 2020

Clinical summary

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

This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).

Study design

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

Arm	Type	Receives
Thermalon	Active comparator	Device: Thermalon Dry Eye CompressParticipants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.
TrueTear™	Experimental	Device: TrueTear™Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.
Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.

Key exclusion criteria (5 listed)

Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.
History of nasal or sinus surgery.
Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.
Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.

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
TrueTear™Intranasal application of TrueTear™ device for approximately 8 minutes at Day 0, for approximately 3 minutes at Day 7 and then daily use of TrueTear™ per participant guide.	Device	TrueTear™
Thermalon Dry Eye CompressApplication of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.	Device	Thermalon

Primary outcome

Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score
Time frame: Baseline (Day 0) to Day 30
MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.
Change From Baseline in MGD Symptoms Questionnaire Score
Time frame: Baseline (Day 0) to Day 30
MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. A negative change from baseline indicates improvement.

Results and safety

Results posted to the registry on 30 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Thermalon	29	29
TrueTear™	28	27

Primary outcome: Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score

Time frame: Baseline (Day 0) to Day 30. Mean (Standard Deviation). Unit: score on scale

Measure	Thermalon n = 29	TrueTear™ n = 27
Computer Usage	-0.4 (0.86)	-0.3 (0.83)
Reading	-0.4 (0.90)	-0.2 (0.79)
Leisure Activities	-0.3 (0.89)	-0.4 (0.89)
Social Activities	-0.2 (0.87)	-0.2 (0.79)
Driving	-0.1 (0.92)	-0.2 (1.05)
Outdoor Activities	-0.3 (0.81)	-0.1 (0.85)
Frequency of Outdoor Activities	-0.2 (0.69)	-0.1 (0.83)
Time Spent to Take Care of Eyes	-0.1 (0.83)	0.1 (0.91)

Thermalon vs TrueTear™: p = 0.9788, Wilcoxon rank-sum test
Thermalon vs TrueTear™: p = 0.6571, Wilcoxon rank-sum test
Thermalon vs TrueTear™: p = 0.4710, Wilcoxon rank-sum test

Population analysed: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.

Primary outcome: Change From Baseline in MGD Symptoms Questionnaire Score

Time frame: Baseline (Day 0) to Day 30. Mean (Standard Deviation). Unit: score on a scale

Measure	Thermalon n = 29	TrueTear™ n = 27
Red Eyes	-0.2 (0.76)	-0.1 (0.83)
Blurred Vision	-0.2 (0.85)	-0.2 (0.80)
Dry Eyes	-0.3 (1.04)	-0.5 (0.85)
Itchy Eyes	-0.8 (1.23)	-0.3 (0.99)
Burning Eyes	-0.2 (0.77)	-0.5 (0.89)
Gritty Eyes	-0.2 (0.99)	-0.4 (0.88)
Painful Eyes	-0.4 (0.87)	-0.1 (0.62)
Watery Eyes	0.0 (1.20)	-0.1 (0.75)

Thermalon vs TrueTear™: p = 0.5457, Wilcoxon rank-sum test
Thermalon vs TrueTear™: p = 0.9786, Wilcoxon rank-sum test
Thermalon vs TrueTear™: p = 0.3894, Wilcoxon rank-sum test

Population analysed: ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.

Adverse events

Time frame: Up to Day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Thermalon	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
TrueTear™	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meibomian Glands

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.

Gail Torkildsen principal investigator

mdlasik@comcast.net

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

Questions about this trial

What is this clinical trial studying?

A study testing TrueTear™ and Thermalon Dry Eye Compress in people with Meibomian Glands and Dry Eye Syndromes, run by Allergan at 1 site 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 2 inclusion and 5 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 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 30 Oct 2020). 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?

Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score (time frame: Baseline (Day 0) to Day 30). 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 NCT03226769.

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 30 Oct 2020.