Tear Production by Nasal Neurostimulation Compared to Active Control

NCT02970799 | Completed Results FDA Device

• 1 other identifier: OCUN-016B
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

Conditions

Dry Eye; Dry Eye Syndromes; Keratoconjunctivitis Sicca

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Acute Tear Production by Jones Schirmer Test

  Day 1

Other Outcomes (7)

• Tear Meniscus Height

  Pre and Post Application on Days 15 and 29

• Tear Meniscus Area

  Pre and Post Application Days 15 and 29

• Number of Secreting Meibomian Glands

  Day 1

Study Arms (2)

Intranasal then Extranasal Application

EXPERIMENTAL

Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.

Device: Intranasal Neurostimulator

Extranasal then Intranasal Application

EXPERIMENTAL

Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.

Device: Intranasal Neurostimulator

Interventions

Intranasal Neurostimulator DEVICE

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Extranasal then Intranasal Application; Intranasal then Extranasal Application

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to severe dry eye disease
• Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
• Literate, able to speak English or Spanish, and able to complete questionnaires independently

You may not qualify if:

• Previously used the Intranasal Neurostimulator at any time
• Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
• Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

Sponsors & Collaborators

• Oculeve, Inc.: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Limitations and Caveats

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 22, 2016
• Study Start: August 31, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2021-09