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

Primary Purpose

Dry Eye Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

P-321 Ophthalmic Solution

P-321 Ophthalmic Solution placebo

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide written informed consent
Male or female subjects aged 18 to 80 years
Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
Have normal lid anatomy
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:

Have undergone refractive eye surgery in either eye during the past 12 months
Have undergone uncomplicated cataract surgery in either eye during the past 3 months
Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
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
Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis

Sites / Locations

Bascom Palmer Eye Institute, University of Miami Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

P-321 Ophthalmic Solution

Drug: P-321 Ophthalmic Solution placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo

Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.

Secondary Outcome Measures

Lower Tear Meniscus Height as Measured by the Keratograph 5M

Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution

Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M

Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution

Adverse Events

Number of patients experiencing adverse events comparing P-321 to placebo

Full Information

NCT ID

NCT02824913

First Posted

July 1, 2016

Last Updated

August 3, 2018

Sponsor

Parion Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02824913

Brief Title

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

Official Title

Randomized, Crossover Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Characterized by Low Tear Volume

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Terminated

Study Start Date

July 2016 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Parion Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P-321 Ophthalmic Solution

Arm Type

Experimental

Arm Description

Arm Title

Drug: P-321 Ophthalmic Solution placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

P-321 Ophthalmic Solution

Other Intervention Name(s)

P-321

Intervention Type

Drug

Intervention Name(s)

P-321 Ophthalmic Solution placebo

Other Intervention Name(s)

Placebo Comparator, Placebo

Primary Outcome Measure Information:

Title

Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo

Description

Time Frame

Pre-dose and up to six hours after dose

Secondary Outcome Measure Information:

Title

Lower Tear Meniscus Height as Measured by the Keratograph 5M

Description

Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution

Time Frame

Pre-dose and up to six hours after dose

Title

Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M

Description

Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution

Time Frame

Pre-dose and up to six hours after dose

Title

Adverse Events

Description

Number of patients experiencing adverse events comparing P-321 to placebo

Time Frame

2 or 7 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide written informed consent Male or female subjects aged 18 to 80 years Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis Have normal lid anatomy Subjects must: 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: Have undergone refractive eye surgery in either eye during the past 12 months Have undergone uncomplicated cataract surgery in either eye during the past 3 months Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed) Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1 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 Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Boyer

Organizational Affiliation

Parion Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Bascom Palmer Eye Institute, University of Miami Health System

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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