Trials Sponsors Conditions Drugs Pricing

Conditions

Dry Eye Syndromes Meibomian Glands

Outcome Measures

Primary Outcomes (2)

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.
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.
Baseline (Day 0) to Day 30

Study Arms (2)

Thermalon

ACTIVE COMPARATOR

Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.

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.

Device: TrueTear™

Interventions

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.

TrueTear™

Thermalon Dry Eye CompressDevice

Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.

Thermalon

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Allergan
Industrylead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title: Therapeutic Area, Head
Organization: Allergan

Study Officials

Gail Torkildsen
mdlasik@comcast.net
PRINCIPAL INVESTIGATOR

Publication Agreements

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

Enrollment

57 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

July 26, 2017

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Thermalon

TrueTear™

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Thermalon

TrueTear™

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations