Trial Outcomes & Findings for Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator (NCT NCT02526290)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

The stimulated and prestimulation (basal) measures were both performed at Day 180.

Results posted on

2017-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Active - Device 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 Study STARTED	97
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Active - Device 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 Study Adverse Event	3
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active - Device n=97 Participants 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
Age, Customized < 50 years	15 participants n=5 Participants
Age, Customized 50 to <60 years	25 participants n=5 Participants
Age, Customized 60 to <70 years	40 participants n=5 Participants
Age, Customized ≥70 years	17 participants n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: The stimulated and prestimulation (basal) measures were both performed at Day 180.

Population: The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.

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.

Outcome measures

Outcome measures
Measure	Active - Device n=89 Participants 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
Stimulated Acute Tear Production Stimulated Schirmer Test	17.28 Scores on a scale Standard Deviation 11.948
Stimulated Acute Tear Production Unstimulated Schirmer Test	7.92 Scores on a scale Standard Deviation 6.386

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.

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).

Outcome measures

Outcome measures
Measure	Active - Device n=94 Participants 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
Corrected Distance Visual Acuity Right Eye	-0.028 LogMAR Standard Deviation 0.0905
Corrected Distance Visual Acuity Left Eye	-0.033 LogMAR Standard Deviation 0.0809

SECONDARY outcome

Timeframe: 6 months

Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.

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.

Outcome measures

Outcome measures
Measure	Active - Device n=97 Participants 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
Slit Lamp Biomicroscopy	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.

Number of subjects who experienced any device-related adverse events.

Outcome measures

Outcome measures
Measure	Active - Device n=97 Participants 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
Device-related Adverse Events Serious device-related AEs	0 participants
Device-related Adverse Events Non-serious device-related AEs	36 participants

Adverse Events

Active - Device

Serious events: 8 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active - Device n=97 participants at risk 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.0% 1/97 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukemia	1.0% 1/97 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	1.0% 1/97 • 6 months
Psychiatric disorders Manic episode secondary to medication non-compliance for bipolar disorder	1.0% 1/97 • 6 months
Infections and infestations Pneumonia	1.0% 1/97 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 1/97 • 6 months
Respiratory, thoracic and mediastinal disorders Shortness of breath (asthma)	1.0% 1/97 • 6 months
Musculoskeletal and connective tissue disorders Left-sided lower back pain with left-sided sciatica	1.0% 1/97 • 6 months

Other adverse events

Other adverse events
Measure	Active - Device n=97 participants at risk 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
Infections and infestations Cold/flu symptoms	18.6% 18/97 • 6 months
Respiratory, thoracic and mediastinal disorders Nasal pain or discomfort	11.3% 11/97 • 6 months
Respiratory, thoracic and mediastinal disorders Nosebleed	6.2% 6/97 • 6 months
Product Issues Transient electrical discomfort	5.2% 5/97 • 6 months

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER