Evaluation of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

This is a multi-center, randomized, double-masked, placebo-controlled, parallel group Phase
2b trial designed to evaluate symptoms and signs in subjects with mild to moderate dry eye
disease. Eligible patients, will be treated with placebo during 2-week placebo run-in period.
Subjects will then be randomly assigned in a double-masked, 1:1 ratio to either 0.017% P-321
Ophthalmic Solution or placebo TID for 28 days. This study is designed to evaluate the
changes in symptoms. Safety will be assessed throughout the study by adverse events.

Inclusion Criteria:

1. Provide written informed consent

2. Male or female subjects aged 18 to 80 years, inclusive

3. Have a history of dry eye disease (DED) in both eyes

4. Be on stable regimens of other needed medications

5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy
Study (ETDRS)

6. Have reported symptoms

7. Have the following signs in at least one eye: Schirmer score without anesthesia of >1
and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.

8. Have normal lid anatomy

Exclusion Criteria:

1. Have undergone refractive eye surgery in the past 12 months

2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not
resulting in exposure or abnormal blinking is allowed)

3. Have lid irregularities or deformities

4. Have a history of glaucoma, a history of an elevated lOP within the past year, or an
lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)

5. Have any clinically significant, uncontrolled, or unstable medical or surgical
conditions that could affect his or her ability to participate

6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct
obstruction. Removable punctal plugs are allowed if they have been used regularly for
at least 60 days prior to the screening visit. However, if a plug comes out during the
study it must be promptly replaced.

7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye

8. Are pregnant or breast feeding

9. Use of any investigational product or device within 28 days prior to the Screening
Visit or during the study