Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

NCT ID: NCT02824913

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-03-31

Brief Summary

The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.

Detailed Description

This is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution under the same study design.

Approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in Phase 1 and the remainder of the 24 subjects participating in the phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.

The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at each treatment visit. Safety assessments include adverse events (AEs).

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

P-321 Ophthalmic Solution

0.017% P-321 Ophthalmic Solution will be administered to approximately 8 patients in Phase I and either 0.05% P-321 Ophthalmic Solution or 0.01% P-321 Ophthalmic Solution or additional 0.017% P-321 Ophthalmic Solution will be administered to approximately 16 patients in Phase II

Group Type: EXPERIMENTAL

P-321 Ophthalmic Solution

Intervention Type: DRUG

Drug: P-321 Ophthalmic Solution placebo

Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II

Group Type: PLACEBO_COMPARATOR

P-321 Ophthalmic Solution placebo

Intervention Type: DRUG

Interventions

P-321 Ophthalmic Solution

Intervention Type: DRUG

P-321 Ophthalmic Solution placebo

Intervention Type: DRUG

Other Intervention Names

P-321; Placebo Comparator; Placebo

Eligibility Criteria

Inclusion Criteria

1. Provide written informed consent

2. Male or female subjects aged 18 to 80 years

3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis

4. Have normal lid anatomy

5. Subjects must:

1. Remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days

Exclusion Criteria

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

2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months

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

4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1

5. Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD

6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.

7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parion Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Boyer

Role: STUDY_DIRECTOR

Parion Sciences

Locations

Bascom Palmer Eye Institute, University of Miami Health System

Plantation, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P-321-201

Identifier Type: -

Identifier Source: org_study_id