Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
18 Years
N/A
Both
Chalazion, Dry Eye Syndromes
Trial Information
Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
Outcome Description:
Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.
Outcome Time Frame:
Baseline, 2 Weeks and 4 Weeks
Safety Issue:
No
Principal Investigator
Christy Stevens, OD
Investigator Role:
Study Director
Investigator Affiliation:
TearScience, Inc.
Authority:
United States: Institutional Review Board
Study ID:
LF001
NCT ID:
NCT00832130
Start Date:
February 2009
Completion Date:
August 2009
Related Keywords:
- Chalazion
- Dry Eye Syndromes
- Chalazion
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Philadelphia, Pennsylvania 19104 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| Little Rock, Arkansas 72205-7199 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina |
