Status:
TERMINATED
Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease
Lead Sponsor:
Allergan
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
22+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03827564
Start Date
June 24 2019
End Date
June 8 2020
Last Update
August 16 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine - Department of Ophthalmology
Houston, Texas, United States, 77030-3411