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Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02526290
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Oculeve, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Dry Eye Syndromes
Keratoconjunctivitis Sicca
Intervention Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active - Device
Hide Arm/Group Description The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Period Title: Overall Study
Started 97
Completed 89
Not Completed 8
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             4
Physician Decision             1
Arm/Group Title Active - Device
Hide Arm/Group Description The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants
< 50 years 15
50 to <60 years 25
60 to <70 years 40
≥70 years 17
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
77
  79.4%
Male
20
  20.6%
1.Primary Outcome
Title Stimulated Acute Tear Production
Hide Description Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.
Time Frame The stimulated and prestimulation (basal) measures were both performed at Day 180.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.
Arm/Group Title Active - Device
Hide Arm/Group Description:
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Stimulated Schirmer Test 17.28  (11.948)
Unstimulated Schirmer Test 7.92  (6.386)
2.Secondary Outcome
Title Corrected Distance Visual Acuity
Hide Description Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received an investigational device and initiated neurostimulation.
Arm/Group Title Active - Device
Hide Arm/Group Description:
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Overall Number of Participants Analyzed 94
Mean (Standard Deviation)
Unit of Measure: LogMAR
Right Eye -0.028  (0.0905)
Left Eye -0.033  (0.0809)
3.Secondary Outcome
Title Slit Lamp Biomicroscopy
Hide Description Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received an investigational device and initiated neurostimulation.
Arm/Group Title Active - Device
Hide Arm/Group Description:
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: participants
0
4.Other Pre-specified Outcome
Title Device-related Adverse Events
Hide Description Number of subjects who experienced any device-related adverse events.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received an investigational device and initiated neurostimulation.
Arm/Group Title Active - Device
Hide Arm/Group Description:
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: participants
Serious device-related AEs 0
Non-serious device-related AEs 36
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active - Device
Hide Arm/Group Description The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Intranasal Lacrimal Neurostimulator (Oculeve): Neurostimulation device
All-Cause Mortality
Active - Device
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Active - Device
Affected / at Risk (%)
Total   8/97 (8.25%) 
Infections and infestations   
Pneumonia *  1/97 (1.03%) 
Musculoskeletal and connective tissue disorders   
Left-sided lower back pain with left-sided sciatica *  1/97 (1.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate cancer *  1/97 (1.03%) 
Chronic lymphocytic leukemia *  1/97 (1.03%) 
Lung adenocarcinoma *  1/97 (1.03%) 
Psychiatric disorders   
Manic episode secondary to medication non-compliance for bipolar disorder *  1/97 (1.03%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism *  1/97 (1.03%) 
Shortness of breath (asthma) *  1/97 (1.03%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active - Device
Affected / at Risk (%)
Total   40/97 (41.24%) 
Infections and infestations   
Cold/flu symptoms *  18/97 (18.56%) 
Product Issues   
Transient electrical discomfort *  5/97 (5.15%) 
Respiratory, thoracic and mediastinal disorders   
Nasal pain or discomfort *  11/97 (11.34%) 
Nosebleed *  6/97 (6.19%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Oculeve, Inc.
ClinicalTrials.gov Identifier: NCT02526290    
Other Study ID Numbers: OCUN-010
First Submitted: August 14, 2015
First Posted: August 18, 2015
Results First Submitted: July 13, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017