Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye

The study objective is to evaluate the long-term treatment effectiveness for adult patients
with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the
LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy
over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with
other MGD and dry eye treatments over a duration of up to 12 Months.

This is a post-market, non-significant risk, prospective and multi-center clinical trial
divided into two stages. The first stage from enrollment to 3 Months is an open-label,
randomized controlled design to compare the effectiveness of a single LipiFlow® System
treatment to a standardized daily warm compress and eyelid hygiene Control therapy with
Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage,
occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness
of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration
of up to 12 Months. Subjects are entered into the following subgroups based on the
subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria
for additional treatment.

1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.

2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.

3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed
by other MGD or dry eye treatment, as prescribed by the physician.