N/A
N=139
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
Chalazion · Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00832130 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Dec 2011
Primary outcome: Primary: Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) — 6.3; 5.6; 14.3; 6.1 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manual Mini System (Device); iHeat Portable Warm Compress Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TearScience, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Meibomian Gland Assessment (Total Meibomian Gland Secretion Score) |
6.3; 5.6; 14.3; 6.1; 16.7; 11.7 | — |
| PRIMARY Incidence of Device-related Adverse Events |
4; 2 | — |
| PRIMARY Tear Break-up Time |
5.5; 5.4; 6.9; 5.3; 7.4; 6.3 | — |
| SECONDARY Dry Eye Symptoms (Total SPEED Score) |
14.3; 14.8; 8.1; 11.2; 7.6; 7.9 | — |
| SECONDARY Ocular Surface Staining (Corneal Staining Sum Score) |
2.2; 2.0; 1.9; 2.0; 1.5; 1.6 | — |
| SECONDARY Intraocular Pressure |
13.3; 14.0; 14.3; 15.0; 12.5; 13.1 | — |
| SECONDARY (LogMAR) Best Spectacle Corrected Visual Acuity |
0.00; 0.01; -0.02; 0.02; -0.02; -0.01 | — |
| SECONDARY Discomfort Evaluation (Discomfort/Pain Score) |
1.4; 0.1; 0.2; 0.0; 0.2; NA | — |
Summary
The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat 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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age.
- Meibomian gland obstruction
- Dry eye symptoms
- Willingness to comply with study procedures and return for all visits
Exclusion Criteria
- Ocular surgery, injury, or 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
- Macular disease
- Systemic disease condition or medication that causes 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 (NCT00832130). 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.