Clinical trial · Interventional
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
Pilot Study for Evaluation of LipiFlow Screening Methods
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chalazion | — | UNRESOLVED | — |
| Dry Eye Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LipiFlow System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LipiFlow Treatment
- description
- Treatment with LipiFlow device
- interventionNames
- Device: LipiFlow System
Primary outcomes (1)
- measure
- Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
- timeFrame
- Baseline and 4 Weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available