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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Parion Sciences
Sponsor:
Information provided by (Responsible Party):
Parion Sciences
ClinicalTrials.gov Identifier:
NCT02831387
First received: July 1, 2016
Last updated: October 3, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye Symptoms.

Condition Intervention Phase
Dry Eye Disease
Drug: P-321 Ophthalmic Solution
Drug: P-321 Ophthalmic Solution placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Masked, Parallel Group Study of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease Assessing Safety and Efficacy Over 28 Days

Resource links provided by NLM:


Further study details as provided by Parion Sciences:

Primary Outcome Measures:
  • Change from baseline (Visit 2) to Day 29 (Visit 4) in the subject-completed symptom questionnaire. [ Time Frame: 29 days ]

Secondary Outcome Measures:
  • Change from baseline (Visit 2) to Day 29 in total symptom scores [ Time Frame: 29 days ]
  • Change from baseline to day 29 in total fluorescein and Lissamine green staining of the cornea and conjunctiva, respectively. [ Time Frame: 29 days ]
  • The proportion of subjects with at least a 20% improvement from baseline to Day 29 in symptom scores [ Time Frame: 29 days ]
  • The proportion of subjects with at an improvement following 14 and 28 days of treatment in symptom scores [ Time Frame: 28 days ]
    Changes from baseline to Day 15 will also be assessed.

  • Safety will be assess by the number of AEs from screening to Day 28 [ Time Frame: 28 days ]

Estimated Enrollment: 60
Study Start Date: July 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.017% P-321 Ophthalmic Solution
0.017% P-321 Ophthalmic Solution TID for 28 days.
Drug: P-321 Ophthalmic Solution
P-321 Ophthalmic Solution 0.017%
Other Name: P-321
Placebo Comparator: Placebo
P-321 Ophthalmic Solution Placebo TID for 28 days.
Drug: P-321 Ophthalmic Solution placebo
Placebo to match P-321 Ophthalmic Solution
Other Name: Placebo

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 a Schirmer score without anesthesia of >1 and <10 mm at 5 minutes in both eyes and have staining of conjunctival and corneal areas of the eye.
  8. Have normal lid anatomy

Exclusion Criteria:

  1. Have undergone refractive eye surgery
  2. Have undergone previous eyelid surgery in either eye
  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)
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02831387

Contacts
Contact: Anita Woodring 919-313-1187

Locations
United States, California
Sall Research Medical Center Recruiting
Artesia, California, United States, 90701
Contact: Letty Guzman    562-804-1974 ext 602    letty@sallresearch.com   
Principal Investigator: Kenneth Sall, MD         
United States, Missouri
Tauber Eye Center Recruiting
Kansas City, Missouri, United States, 64111
Contact: Megan Hefter    816-531-9100    mh@taubereye.com   
Principal Investigator: Joseph Tauber, MD         
Ophthalmology Associates Recruiting
St. Louis, Missouri, United States, 63131
Contact: Debi Gravemann    314-966-3377    debi.gravemann@youreyedoc.com   
Principal Investigator: Gregg Berdy, MD         
Comprehensive Eye Care, Ltd. Recruiting
Washington, Missouri, United States, 63090
Contact: Janet R Zeitzman, RN    636-390-3999    rzeitzmann@geccobilling.com   
Principal Investigator: Michael Korenfeld, MD         
United States, North Carolina
UNC Kittner Eye Center Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Elizabeth DuBose    919-974-2057    Elizabeth_dubose@med.unc.edu   
Principal Investigator: Richard M Davis         
United States, Texas
Ocular Surface Center, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Tejal Patel    713-798-4125    tejal.patel@bcm.edu   
Principal Investigator: Stephen Pflugfelder, MD         
United States, Virginia
Virginia Eye Consultants Recruiting
Norfolk, Virginia, United States, 23502
Contact: Lisa Dyer    757-961-2950    lfelix@vec2020.com   
Principal Investigator: John Sheppard         
Sponsors and Collaborators
Parion Sciences
  More Information

Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT02831387     History of Changes
Other Study ID Numbers: P-321-202
Study First Received: July 1, 2016
Last Updated: October 3, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions

ClinicalTrials.gov processed this record on April 28, 2017