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

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).

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