- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202747
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Pilot Study for Evaluation of LipiFlow Screening Methods
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Hoffman Estates, Illinois, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
Winchester, Massachusetts, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LipiFlow Treatment
Treatment with LipiFlow device
|
In-office treatment for meibomian gland dysfunction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
Time Frame: Baseline and 4 Weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christy Stevens, OD, TearScience
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LF002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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