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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Parion Sciences
ClinicalTrials.gov Identifier:
NCT02831387
First received: July 1, 2016
Last updated: June 2, 2017
Last verified: June 2017
  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: 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: July 2017
Estimated Primary Completion Date: July 2017 (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 the following sings 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
  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

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090
United States, North Carolina
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States, 27517
United States, Texas
Ocular Surface Center, Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
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: June 2, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 June 26, 2017