Clinical trial NCT00832130: Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Official title: Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chalazion
Dry Eye Syndromes
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Meibomian gland obstruction
* Dry eye symptoms
* Willingness to comply with study procedures and return for all visits

Exclusion Criteria:

* Ocular surgery, injury, or herpes infection within past 3 months
* Active ocular infection
* Active ocular inflammation or recurrent inflammation within past 3 months
* Moderate to severe allergic conjunctivitis
* Severe eyelid inflammation
* Eyelid abnormalities that affect lid function
* Ocular surface abnormalities that may compromise corneal integrity
* Macular disease
* Systemic disease condition or medication that causes dry eye
* Use of other treatments for meibomian gland dysfunction or dry eye
* Pregnant or nursing women
* Participation in another ophthalmic clinical trial within past 30 days

Primary outcomes:
measure: Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
timeFrame: Baseline, 2 Weeks and 4 Weeks
measure: Incidence of Device-related Adverse Events
timeFrame: Baseline through 4 Weeks
measure: Tear Break-up Time
timeFrame: Baseline, 2 Weeks and 4 Weeks
Secondary outcomes:
measure: Dry Eye Symptoms (Total SPEED Score)
timeFrame: Baseline, 2 Weeks and 4 Weeks
measure: Ocular Surface Staining (Corneal Staining Sum Score)
timeFrame: Baseline through 4 Weeks
measure: Intraocular Pressure
timeFrame: Baseline through 4 Weeks
measure: (LogMAR) Best Spectacle Corrected Visual Acuity
timeFrame: Baseline, 2 Weeks and 4 Weeks
measure: Discomfort Evaluation (Discomfort/Pain Score)
timeFrame: Treatment and 1 Day
Other outcomes:
Locations:
city: Fayetteville
country: United States
state: Arkansas
city: Morrow
country: United States
state: Georgia
city: Highland Park
country: United States
state: Illinois
city: Edgewood
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Winchester
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Bloomington
country: United States
state: Minnesota
city: Stillwater
country: United States
state: Minnesota
city: Charlotte
country: United States
state: North Carolina
city: Lancaster
country: United States
state: Pennsylvania
Study officials:
affiliation: TearScience, Inc.
name: Christy Stevens, OD
role: STUDY_DIRECTOR
References: