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Trial record 4 of 10 for:    parion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824913
Recruitment Status : Terminated
First Posted : July 7, 2016
Results First Posted : January 19, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Parion Sciences

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: P-321 Ophthalmic Solution Drug: P-321 Ophthalmic Solution placebo Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
Experimental: 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
Drug: P-321 Ophthalmic Solution
Other Name: P-321

Placebo Comparator: Drug: P-321 Ophthalmic Solution placebo
Placebo treatment administered to approximately 8 patients in Phase I and approximately 16 patients in Phase II
Drug: P-321 Ophthalmic Solution placebo
Other Names:
  • Placebo Comparator
  • Placebo




Primary Outcome Measures :
  1. Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo [ Time Frame: Pre-dose and up to six hours after dose ]
    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 :
  1. Lower Tear Meniscus Height as Measured by the Keratograph 5M [ Time Frame: Pre-dose and up to six hours after dose ]
    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

  2. Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M [ Time Frame: Pre-dose and up to six hours after dose ]
    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

  3. Adverse Events [ Time Frame: 2 or 7 hours ]
    Number of patients experiencing adverse events comparing P-321 to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824913


Locations
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United States, Florida
Bascom Palmer Eye Institute, University of Miami Health System
Plantation, Florida, United States, 33324
Sponsors and Collaborators
Parion Sciences
Investigators
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Study Director: Jose Boyer Parion Sciences
  Study Documents (Full-Text)

Documents provided by Parion Sciences:

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Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT02824913     History of Changes
Other Study ID Numbers: P-321-201
First Posted: July 7, 2016    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: August 31, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions