MedDataX Logo

Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

NCT ID: NCT01202747

Last Updated: 2011-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chalazion Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LipiFlow Treatment

Treatment with LipiFlow device

Group Type EXPERIMENTAL

LipiFlow System

Intervention Type DEVICE

In-office treatment for meibomian gland dysfunction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LipiFlow System

In-office treatment for meibomian gland dysfunction

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TearScience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christy Stevens, OD

Role: STUDY_DIRECTOR

TearScience

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hoffman Estates, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Winchester, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LF002

Identifier Type: -

Identifier Source: org_study_id