NCT04229888CompletedNot Applicable
Meibomian Gland Dysfunction Treatment
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Dry Eye Questionnaire 5 (DEQ-5) Score
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •evidence of meibomian gland obstruction in both eyes
- •dry eye symptoms per DEQ-5
Exclusion Criteria
- •active ocular infection
- •previous LipiFlow treatment
- •beginning new oral or other systemic medications within prior 3 months
- •beginning new or changing dosages of ocular medications within prior 3 months
- •previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
- •habitual contact lens wear in prior 3 months
- •women who are pregnant or nursing
Outcomes
Primary Outcomes
Dry Eye Questionnaire 5 (DEQ-5) Score
Time Frame: 2 weeks
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
Secondary Outcomes
- Tear Break-Up Time (TBUT)(2 weeks)
- Meibomian Gland Score(2 weeks)
Investigators
Anna Tichenor
Assistant Scientist
Indiana University
Study Sites (2)
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