A Phase 2/3 interventional study of LipiFlow System in Chalazion and Dry Eye Syndromes, sponsored by TearScience, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-06.
Sponsored by TearScience, Inc. · Phase 2/3, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →TearScience, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Treatment with LipiFlow device
Device: LipiFlow System
In-office treatment for meibomian gland dysfunction
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.
Time frame: Baseline and 4 Weeks
A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.
| Milestone | LipiFlow Treatment |
|---|---|
| Started | 50 |
| Completed | 49 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Correlation coefficient | LipiFlow Treatment |
|---|---|
| Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | 0.4816 |
Collected over 4 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LipiFlow Treatment | — | 0/50 (0%) | 0/50 (0%) |
| Age Continuous(years) | LipiFlow Treatment |
|---|---|
| Mean | 49.8 ± 15.9 |
| Sex: Female, Male(Participants) | LipiFlow Treatment |
|---|---|
| Female | 35 |
| Male | 15 |
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Chalazion
TearScience, Inc.