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Neurostimulator

ITN [TrueTear®] - Extranasal Application for Dry Eye Syndrome

N/A
Waitlist Available
Led By Stephen Pflugfelder, MD
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (day -60 to day -30) to application visit (day 0)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -60 to day -30) to application visit (day 0)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day -60 to day -30) to application visit (day 0) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Ratio of Degranulated Goblet Cells.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ITN [TrueTear®] - Intranasal ApplicationExperimental Treatment1 Intervention
Intranasal application of the ITN. Single application at application visit.
Group II: ITN [TrueTear®] - Extranasal ApplicationExperimental Treatment1 Intervention
Extranasal application of the ITN. Single application at application visit.

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,640 Total Patients Enrolled
Stephen Pflugfelder, MDPrincipal InvestigatorBaylor College of Medicine, Department of Ophthalmology
1 Previous Clinical Trials
20 Total Patients Enrolled
~2 spots leftby Oct 2025
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