Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

Completed · Not applicable

Conditions studied: Meibomian Gland Dysfunction, Dry Eye

In brief

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.

Key facts

Study ID

NCT02102464

Run by

TearScience, Inc.

People needed

55

Starts

2014-04-01

Expected to finish

2015-09-01

Last updated by the study team

2017-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• School of Optometry, The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Clayton Eye Center — Morrow, Georgia, United States
• Charlotte Eye Ear Nose and Throat Associates, P.A. — Charlotte, North Carolina, United States
• May Eye Care Center & Associates — Hanover, Pennsylvania, United States
• Specialty Eyecare Group — Kirkland, Washington, United States
• Centre for Contact Lens Research — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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