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

NCT02824913 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: P-321-201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-dose and up to six hours after dose

Secondary Outcomes (3)

• Lower Tear Meniscus Height as Measured by the Keratograph 5M

  Pre-dose and up to six hours after dose

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

  Pre-dose and up to six hours after dose

• Adverse Events

  2 or 7 hours

Study Arms (2)

P-321 Ophthalmic Solution

EXPERIMENTAL

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

Drug: P-321 Ophthalmic Solution

Drug: P-321 Ophthalmic Solution placebo

PLACEBO COMPARATOR

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

Drug: P-321 Ophthalmic Solution placebo

Interventions

P-321 Ophthalmic Solution DRUG

Also known as: P-321

P-321 Ophthalmic Solution

P-321 Ophthalmic Solution placebo DRUG

Also known as: Placebo Comparator, Placebo

Drug: P-321 Ophthalmic Solution placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parion Sciences: lead

Study Sites (1)

Bascom Palmer Eye Institute, University of Miami Health System

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jose Boyer
• Organization: Parion Sciences

jboyer@parion.com

919-313-1182

Study Officials

• Jose Boyer

  Parion Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 31, 2018
• Results First Posted: January 19, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)