Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

This is a Phase II, multi-center, double-masked, randomized, vehicle-controlled,
parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic
suspension versus vehicle in subjects with dry eye disease.

Approximately 400 subjects will be screened and up to 150 subjects will be randomized at up
to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms
in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension
administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2
drops in each eye QID for up to 28 days.

This study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days
prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week
run-in period during which they will be treated with 1-2 drops of single-masked vehicle in
each eye QID for 14 ± 1 days.

At Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria
will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25%
ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to
return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1
day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the
clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ±
1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final
study visit will occur upon completion of 28 ± 1 days of exposure to investigational product.
Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day).

Inclusion Criteria:

• Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

- Known hypersensitivity/contraindication to study product(s) or components.

- History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being
treated for glaucoma in either eye.

- Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
judgment of Investigator could confound study assessments or limit compliance;
severe/serious systemic disease or uncontrolled medical condition that in judgment of
Investigator could confound study assessments or limit compliance; or have been
exposed to an investigational drug within the 30 days prior to screening.

- In the opinion of Investigator or study coordinator, be unwilling or unable to comply
with study protocol or unable to successfully instill eye drops.