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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).

Official Title
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Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers

Conditions
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Meibomian Gland Dysfunction, Dry Eye

Intervention / Treatment
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* Device: LipiFlow treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LipiFlow<br>Single 12-minute LipiFlow treatment | Device: LipiFlow treatment<br>* The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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.<br>* Other names: LipiFlow® Thermal Pulsation System;|
| No Intervention: Untreated Control<br>Untreated Control (No Intervention) | |
| Experimental: Crossover LipiFlow Treatment<br>Crossover LipiFlow treatment of the untreated control group after 3 months | Device: LipiFlow treatment<br>* The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure 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.<br>* Other names: LipiFlow® Thermal Pulsation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Meibomian Gland Score From Baseline at 3 Months | The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months | The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms. | 3 Months |