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Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03827564
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®] Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
Experimental: ITN [TrueTear®] - Intranasal Application
Intranasal application of the ITN. Single application at application visit.
Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.

Experimental: ITN [TrueTear®] - Extranasal Application
Extranasal application of the ITN. Single application at application visit.
Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.




Primary Outcome Measures :
  1. Mean change in goblet cell degranulation post-intranasal use of the ITN at the Application visit compared to without use of the ITN at the Screening visit [ Time Frame: Screening (Day -60 to Day -30) to Application Visit (Day 0) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
  • Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
  • The participant should be literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

  • Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
  • Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
  • Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
  • Corneal transplant in either or both eyes
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
  • Women who are pregnant, planning a pregnancy, or nursing throughout the study

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): NCT03827564


Contacts
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Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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United States, Texas
Baylor College of Medicine - Department of Ophthalmology Not yet recruiting
Houston, Texas, United States, 77030-3411
Sponsors and Collaborators
Allergan
Investigators
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Principal Investigator: Stephen Pflugfelder, MD Baylor College of Medicine, Department of Ophthalmology

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03827564     History of Changes
Other Study ID Numbers: 1919-802-019
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Allergan:
Dry Eye Disease

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