Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Dry Eye Syndromes Clinical Trial

Official title:

Pilot Study for Evaluation of LipiFlow Screening Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202747
• Other study ID #: LF002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 14, 2010
• Last updated: November 1, 2011
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: November 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 is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure 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. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meibomian gland dysfunction

• Dry Eye symptoms

Exclusion Criteria:

• Ocular surgery, ocular injury or ocular 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

• Systemic disease conditions or medications that cause 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chalazion
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• LipiFlow System
In-office treatment for meibomian gland dysfunction

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	Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)	Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.; Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.	Baseline and 4 Weeks	No