Clinical trial NCT02910713: Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
Official title: Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 185
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

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

Primary outcomes:
measure: Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
timeFrame: Pre-application to Post-application on Day 0
Secondary outcomes:
measure: Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
timeFrame: Pre-application to Post-application on Day 0
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eye Care Institute
state: Kentucky
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
Study officials:
affiliation: Allergan
name: Michelle Senchyna
role: STUDY_CHAIR
References: