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

• Status: Terminated
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parion Sciences
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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