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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.017% P-321 Ophthalmic Solution

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

Group Type EXPERIMENTAL

P-321 Ophthalmic Solution

Intervention Type DRUG

P-321 Ophthalmic Solution 0.017%

Placebo

P-321 Ophthalmic Solution Placebo TID for 28 days.

Group Type PLACEBO_COMPARATOR

P-321 Ophthalmic Solution placebo

Intervention Type DRUG

Placebo to match P-321 Ophthalmic Solution

Interventions

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P-321 Ophthalmic Solution

P-321 Ophthalmic Solution 0.017%

Intervention Type DRUG

P-321 Ophthalmic Solution placebo

Placebo to match P-321 Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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P-321 Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No