Phase 3 N=50 Treatment

Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Chalazion · Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT01202747 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcome: Primary: Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) — 0.4816 Correlation coefficient — p=0.0005

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LipiFlow System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: TearScience, Inc.
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)	0.4816	0.0005 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01202747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.