Chalazion, Dry Eye Syndromes
Conditions
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.
Interventions
DEVICELipiFlow System
In-office treatment for meibomian gland dysfunction
Sponsors
TearScience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.
Participants by arm
| Arm | Count |
|---|---|
| LipiFlow Treatment Treatment with LipiFlow device | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | LipiFlow Treatment |
|---|---|
| Age Continuous | 49.8 years STANDARD_DEVIATION 15.9 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: Baseline and 4 Weeks
Population: Results presented are for the Intent to Treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LipiFlow Treatment | Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | 0.4816 Correlation coefficient |
p-value: 0.0005Regression, Linear