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

Parion Sciences

Status and phase: Terminated; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: P-321 Ophthalmic Solution placebo; Drug: P-321 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02831387

P-321-202

Details and patient eligibility

About

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

Full description

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

0.017% P-321 Ophthalmic Solution

Experimental group

Description:

0.017% P-321 Ophthalmic Solution TID for 28 days.

Treatment:

Drug: P-321 Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

P-321 Ophthalmic Solution Placebo TID for 28 days.

Treatment:

Drug: P-321 Ophthalmic Solution placebo