A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

• Sponsor: Oculeve, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02680158
• Collaborator: (none)
• Enrollment: 48
• Locations: 2
• Arms: 6
• Actual Duration (Months): 2
• Patients Per Site: 24
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome; Keratoconjunctivitis Sicca	Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal	N/A

Detailed Description

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Three way cross-over study with 6 sequences.Three way cross-over study with 6 sequences.
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye
• Actual Study Start Date: Jan 31, 2016
• Actual Primary Completion Date: Mar 31, 2016
• Actual Study Completion Date: Mar 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1-Intranasal: Extranasal: Sham Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: Sequence 2-Intranasal: Sham: Extranasal Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: Sequence 3-Extranasal: Intranasal: Sham Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: Sequence 4-Extranasal: Sham: Intranasal Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: Sequence 5-Sham: Intranasal: Extranasal Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: Sequence 6-Sham: Extranasal: Intranasal Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Device: Oculeve Intranasal; Oculeve device, intranasal (test) application for approximately 3 minutes.; Device: Sham; Sham device (control), intranasal application for approximately 3 minutes.; Device: Oculeve Extranasal; Oculeve device, extranasal (control) application for approximately 3 minutes.

Outcome Measures

Primary Outcome Measures

1. Acute Stimulated Tear Production [Day 0 post-application]

   Stimulated acute tear production in the study eye at Day 0 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. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.

2. Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) [Day 0]

   An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.

Other Outcome Measures

1. Corrected Distance Visual Acuity [1-Day]

2. Slit Lamp Biomicroscopy [1-Day]

3. Pulse Rate [1-Day]

4. Oxygen Saturation [1-Day]

5. Blood Pressure [1-Day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with aqueous tear deficiency

• Literate, able to speak English or Spanish, and able to complete questionnaires independently

• Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding

• Nasal or sinus surgery including nasal cautery or significant trauma

• Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

• Diagnosis of epilepsy

• Corneal transplant in either or both eyes

• Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

• A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Eye Care Group	Waterbury	Connecticut	United States	06708
2	Virginia Eye Consultants	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Oculeve, Inc.

Investigators

• Study Director: Michelle Senchyna, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oculeve, Inc.
• ClinicalTrials.gov Identifier: NCT02680158
• Other Study ID Numbers: OCUN-009
• First Posted: Feb 11, 2016
• Last Update Posted: Apr 26, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Syndrome

Study Results

Participant Flow

Arm/Group Title	Sequence 1 - Intranasal : Extranasal : Sham	Sequence 2 - Intranasal : Sham : Extranasal	Sequence 3 - Extranasal: Intranasal: Sham	Sequence 4 - Extranasal : Sham : Intranasal	Sequence 5 - Sham : Intranasal : Extranasal	Sequence 6 - Sham : Extranasal : Intranasal
Arm/Group Description	Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.	Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Period Title: Overall Study
STARTED	8	8	8	8	8	8
COMPLETED	8	8	8	8	8	8
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0.
Overall Participants	48
Overall eyes	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.9 (13.17)
Sex: Female, Male (Count of Participants)
Female	39 81.3%
Male	9 18.8%

Outcome Measures

1. Primary Outcome

Title	Acute Stimulated Tear Production
Description	Stimulated acute tear production in the study eye at Day 0 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. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Time Frame	Day 0 post-application

Outcome Measure Data

Analysis Population Description

The FAS population included all randomized participants who were exposed to study application.

Arm/Group Title	Oculeve Intranasal	Sham	Oculeve Extranasal
Arm/Group Description	Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0	Sham device (control), intranasal application for approximately 3 minutes on Day 0	Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
Measure Participants	48	48	48
Measure eyes	48	48	48
Mean (Standard Deviation) [mm]	25.3 (10.70)	9.2 (7.34)	9.5 (8.15)

2. Primary Outcome

Title	Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Description	An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Safety population included all randomized participants who were exposed to study application.

Arm/Group Title	Oculeve Intranasal	Sham	Oculeve Extranasal
Arm/Group Description	Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0	Sham device (control), intranasal application for approximately 3 minutes on Day 0	Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
Measure Participants	48	48	48
Measure eyes	48	48	48
Device-related AEs (Ocular)	0 0%	0 0%	0 NaN
Device-related AEs (Non-ocular)	4.2 8.8%	0 0%	0 NaN

3. Other Pre-specified Outcome

Title	Corrected Distance Visual Acuity
Time Frame	1-Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Slit Lamp Biomicroscopy
Time Frame	1-Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Pulse Rate
Time Frame	1-Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Oxygen Saturation
Time Frame	1-Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Blood Pressure
Time Frame	1-Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Day 0
Adverse Event Reporting Description	Safety population included all randomized participants who were exposed to study applications.
Arm/Group Title	Oculeve Intranasal		Sham		Oculeve Extranasal
Arm/Group Description	Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0		Sham device (control), intranasal application for approximately 3 minutes on Day 0		Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0
All Cause Mortality
	Oculeve Intranasal		Sham		Oculeve Extranasal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)		0/48 (0%)
Serious Adverse Events
	Oculeve Intranasal		Sham		Oculeve Extranasal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Oculeve Intranasal		Sham		Oculeve Extranasal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/48 (8.3%)		0/48 (0%)		0/48 (0%)
Eye disorders
Corneal abrasion	1/48 (2.1%)		0/48 (0%)		0/48 (0%)
General disorders
Slight transient lightheadedness	1/48 (2.1%)		0/48 (0%)		0/48 (0%)
Intermittent nose itching	1/48 (2.1%)		0/48 (0%)		0/48 (0%)
Exacerbation of hypertension	1/48 (2.1%)		0/48 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.