Phase 3
Completed N=50
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Chalazion · Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01202747 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) — 0.4816 Correlation coefficient — p=0.0005
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.
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 |
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
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. Informational only — not medical advice.