Study Stopped
Study discontinued due to business reasons.
Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2020
CompletedResults Posted
Study results publicly available
August 16, 2021
CompletedAugust 16, 2021
July 1, 2021
12 months
January 31, 2019
June 8, 2021
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Ratio of Degranulated Goblet Cells.
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Screening (Day -60 to Day -30) to Application Visit (Day 0)
Study Arms (2)
ITN [TrueTear®] - Intranasal Application
EXPERIMENTALIntranasal application of the ITN. Single application at application visit.
ITN [TrueTear®] - Extranasal Application
EXPERIMENTALExtranasal application of the ITN. Single application at application visit.
Interventions
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Baylor College of Medicine - Department of Ophthalmology
Houston, Texas, 77030-3411, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early, resulting in a small number of patients analyzed. Only a descriptive statistical analysis will be performed.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Pflugfelder, MD
Baylor College of Medicine, Department of Ophthalmology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 1, 2019
Study Start
June 24, 2019
Primary Completion
June 8, 2020
Study Completion
June 8, 2020
Last Updated
August 16, 2021
Results First Posted
August 16, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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/.