NCT02385292

Brief Summary

The objectives of this study are:

  • To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
  • To compare the goblet cell count following application between the intranasal and extranasal applications
  • To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

October 19, 2021

Completed
Last Updated

October 19, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

March 2, 2015

Results QC Date

September 22, 2021

Last Update Submit

September 22, 2021

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • Fluorescein Tear Clearance With Application

    Day 1

Other Outcomes (3)

  • Level of Tear Proteins Pre and Post Administration

    Day 1

  • Level of Inflammatory Mediators Pre and Post Administration

    Day 1

  • Goblet Cell Count Following Application

    Day 1

Study Arms (2)

Intranasal then Extranasal Application

EXPERIMENTAL

Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Device: Oculeve Intranasal Lacrimal Neurostimulator

Extranasal then Intranasal Application

ACTIVE COMPARATOR

Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Device: Oculeve Intranasal Lacrimal Neurostimulator

Interventions

Oculeve Intranasal Lacrimal NeurostimulatorDEVICE

The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Extranasal then Intranasal ApplicationIntranasal then Extranasal Application

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral dry eyes
  • Capable of providing written informed consent

You may not qualify if:

  • Chronic or recurring epistaxis (nosebleeds)
  • Blood coagulation disorder
  • Uncontrolled or poorly controlled diabetes
  • Heart or pulmonary disease
  • Females who are pregnant, planning a pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grutzmacher, Lewis & Sierra

Sacramento, California, 95815, United States

Location

Baylor College of Medicine, Department of Ophthalmology

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.

    PMID: 28302532DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye 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

  • Richard Lewis, MD

    Grutzmacher, Lewis & Sierra

    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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

May 31, 2015

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

October 19, 2021

Results First Posted

October 19, 2021

Record last verified: 2021-09

Locations

US(2)