Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

NCT01202747 | Completed Phase 2 Results

• 1 other identifier: LF002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chalazion; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LipiFlow Treatment

EXPERIMENTAL

Treatment with LipiFlow device

Device: LipiFlow System

Interventions

LipiFlow System DEVICE

In-office treatment for meibomian gland dysfunction

LipiFlow Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meibomian gland dysfunction
• Dry Eye symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• TearScience, Inc.: lead

Study Sites (3)

Unknown Facility

Hoffman Estates, Illinois, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Winchester, Massachusetts, United States

Location

MeSH Terms

Conditions

Chalazion; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Christy Stevens, OD
• Organization: TearScience, Inc. (formerly Kolis Scientific)

cstevens@tearscience.com

919-459-4815

Study Officials

• Christy Stevens, OD

  TearScience

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 6, 2011
• Results First Posted: December 6, 2011

Record last verified: 2011-11

Locations

US (3)