N/A
N=55
Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
Meibomian Gland Dysfunction · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT02102464 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Mean Change in Meibomian Gland Score From Baseline at 3 Months — 12.4; 1.4 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LipiFlow treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TearScience, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Meibomian Gland Score From Baseline at 3 Months |
12.4; 1.4 | <0.0001 sig |
| SECONDARY Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months |
-8.4; -0.7 | <0.0001 sig |
Summary
The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of meibomian gland dysfunction and dry eye
- At least 18 years of age
- Willing to comply with randomization, attend all study visits and follow patient instructions
- Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
- No change in contact lens type or dimensions for the past 3 months
- Clinician assessment of acceptable contact lens fit and disinfecting solution
- Tear film interferometry of 100 units or less
Exclusion Criteria
- Systemic disease conditions that cause dry eye
- Use of systemic medications known to cause dryness
- History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
- Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
- Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
- Participation in another ophthalmic drug or device trial in the past month
- Employee, relative of employee or associate of the clinical site
Data sourced from ClinicalTrials.gov (NCT02102464). 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.