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

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