NCT02526290

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

Completed NA Results posted Last updated 31 October 2017

What this trial tests

NA trial testing Intranasal Lacrimal Neurostimulator (Oculeve) in Dry Eye Syndromes in 97 participants. Completed in 30 April 2016.

Timeline

31 August 2015

Primary endpoint
30 April 2016

30 April 2016

Quick facts

Lead sponsor	Oculeve, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	97
Start date	31 August 2015
Primary completion	30 April 2016
Estimated completion	30 April 2016
Sites	3 locations across United States

Drugs / interventions tested

• Intranasal Lacrimal Neurostimulator (Oculeve)

Conditions studied

• Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
• Keratoconjunctivitis Sicca — all drugs for Keratoconjunctivitis Sicca →

Sponsor

Oculeve, Inc.

Who can join

22 and older, any sex, with Dry Eye Syndromes or Keratoconjunctivitis Sicca. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stimulated Acute Tear Production Primary · The stimulated and prestimulation (basal) measures were both performed at Day 180.

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.

Stimulated Schirmer Test

Group	Value	95% CI
Active - Device	17.28	± 11.948

Unstimulated Schirmer Test

Group	Value	95% CI
Active - Device	7.92	± 6.386

Corrected Distance Visual Acuity Secondary · Baseline and 6 months

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).

Right Eye

Group	Value	95% CI
Active - Device	-0.028	± 0.0905

Left Eye

Group	Value	95% CI
Active - Device	-0.033	± 0.0809

Slit Lamp Biomicroscopy Secondary · 6 months

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 potenti

Group	Value	95% CI
Active - Device	0

Device-related Adverse Events Secondary · 6 months

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

Serious device-related AEs

Group	Value	95% CI
Active - Device	0

Non-serious device-related AEs

Group	Value	95% CI
Active - Device	36

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active - Device

Serious: 8/97 (8%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Active - Device
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Chronic lymphocytic leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Manic episode secondary to medication non-compliance for bipolar disorder	Psychiatric disorders	—
Pneumonia	Infections and infestations	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Shortness of breath (asthma)	Respiratory, thoracic and mediastinal disorders	—
Left-sided lower back pain with left-sided sciatica	Musculoskeletal and connective tissue disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Active - Device
Cold/flu symptoms	Infections and infestations	—
Nasal pain or discomfort	Respiratory, thoracic and mediastinal disorders	—
Nosebleed	Respiratory, thoracic and mediastinal disorders	—
Transient electrical discomfort	Product Issues	—

Most-reported serious reactions: Prostate cancer, Chronic lymphocytic leukemia, Lung adenocarcinoma, Manic episode secondary to medication non-compliance for bipolar disorder, Pneumonia, Pulmonary embolism, Shortness of breath (asthma), Left-sided lower back pain with left-sided sciatica.

Data from ClinicalTrials.gov NCT02526290 adverse events section.

Sponsor's own description

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials.
   Sheppard JD, Torkildsen GL, Geffin JA, Dao J, et al · · 2019 · cited 24× · PMID 30472141 · DOI 10.1016/j.jtos.2018.11.009