An interventional study of Intranasal Lacrimal Neurostimulator (Oculeve) in Dry Eye Syndromes and Keratoconjunctivitis Sicca, sponsored by Oculeve, Inc.. Completed at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Oculeve, Inc. · Not applicable, Interventional, and Supportive care
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.
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 97 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Oculeve, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration.
Device: Intranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device
Stimulated Acute Tear Production
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.
Corrected Distance Visual Acuity
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
Slit Lamp Biomicroscopy
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
Device-related Adverse Events
Number of subjects who experienced any device-related adverse events.
Time frame: 6 months
| Milestone | Active - Device |
|---|---|
| Started | 97 |
| Completed | 89 |
| Not completed | 8 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Physician decision | 1 |
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.
| Scores on a scale | Active - Device |
|---|---|
| Stimulated Schirmer Test | 17.28 ± 11.948 |
| Unstimulated Schirmer Test | 7.92 ± 6.386 |
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).
| LogMAR | Active - Device |
|---|---|
| Right Eye | -0.028 ± 0.0905 |
| Left Eye | -0.033 ± 0.0809 |
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.
| participants | Active - Device |
|---|---|
| Slit Lamp Biomicroscopy | 0 |
Number of subjects who experienced any device-related adverse events.
| participants | Active - Device |
|---|---|
| Serious device-related AEs | 0 |
| Non-serious device-related AEs | 36 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active - Device | — | 8/97 (8.2%) | 40/97 (41.2%) |
| Event | Active - Device |
|---|---|
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 |
| Chronic lymphocytic leukemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/97 |
| Manic episode secondary to medication non-compliance for bipolar disorderPsychiatric disorders | 1/97 |
| PneumoniaInfections and infestations | 1/97 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/97 |
| Shortness of breath (asthma)Respiratory, thoracic and mediastinal disorders | 1/97 |
| Left-sided lower back pain with left-sided sciaticaMusculoskeletal and connective tissue disorders | 1/97 |
| Event | Active - Device |
|---|---|
| Cold/flu symptomsInfections and infestations | 18/97 |
| Nasal pain or discomfortRespiratory, thoracic and mediastinal disorders | 11/97 |
| NosebleedRespiratory, thoracic and mediastinal disorders | 6/97 |
| Transient electrical discomfortProduct Issues | 5/97 |
| Age, Customized(participants) | Active - Device |
|---|---|
| < 50 years | 15 |
| 50 to <60 years | 25 |
| 60 to <70 years | 40 |
| ≥70 years | 17 |
| Sex: Female, Male(Participants) | Active - Device |
|---|---|
| Female | 77 |
| Male | 20 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Oculeve, Inc.