N/A
N=185
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02910713 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) — -16.48; -3.12 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Tear Neurostimulator (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) |
-16.48; -3.12 | <0.0001 sig |
| SECONDARY Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score |
-0.93; -0.34 | <0.0001 sig |
Summary
This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe dry eye disease
- Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- 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 risk of clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
- Corneal transplant in either or both eyes
- A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Data sourced from ClinicalTrials.gov (NCT02910713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.