Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Dry Eye Syndromes Clinical Trial

Official title:

Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832130
• Other study ID #: LF001
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: December 5, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2011
• Source: TearScience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chalazion
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Manual Mini System
In-office device treatment for meibomian gland dysfunction by a physician
• iHeat Portable Warm Compress Therapy
At-home daily warm compress therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TearScience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)	Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.	Baseline, 2 Weeks and 4 Weeks	No
Primary	Incidence of Device-related Adverse Events	Number of eyes for which a device-related AE occurred	Baseline through 4 Weeks	Yes
Primary	Tear Break-up Time	Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.	Baseline, 2 Weeks and 4 Weeks	No
Secondary	Dry Eye Symptoms (Total SPEED Score)	Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.	Baseline, 2 Weeks and 4 Weeks	No
Secondary	Ocular Surface Staining (Corneal Staining Sum Score)	Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.	Baseline through 4 Weeks	Yes
Secondary	Intraocular Pressure	Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.	Baseline through 4 Weeks	Yes
Secondary	(LogMAR) Best Spectacle Corrected Visual Acuity	Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.	Baseline, 2 Weeks and 4 Weeks	Yes
Secondary	Discomfort Evaluation (Discomfort/Pain Score)	Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.	Treatment and 1 Day	Yes