Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
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|ClinicalTrials.gov Identifier: NCT02526290|
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes Keratoconjunctivitis Sicca||Device: Intranasal Lacrimal Neurostimulator (Oculeve)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye|
|Actual Study Start Date :||August 31, 2015|
|Actual Primary Completion Date :||April 30, 2016|
|Actual Study Completion Date :||April 30, 2016|
Experimental: Active - Device
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)
- Stimulated Acute Tear Production [ Time Frame: 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.
- Corrected Distance Visual Acuity [ Time Frame: 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).
- Slit Lamp Biomicroscopy [ Time Frame: 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 potential AE by the investigator.
- Device-related Adverse Events [ Time Frame: 6 months ]Number of subjects who experienced any device-related adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526290
|United States, Arizona|
|Cornea & Cataract Consultants of Arizona|
|Phoenix, Arizona, United States, 85032|
|United States, Massachusetts|
|Andover Eye Associates|
|Andover, Massachusetts, United States, 01810|
|United States, Tennessee|
|Total Eye Care|
|Memphis, Tennessee, United States, 38119|
|Study Director:||Edward Holland, MD||Cincinnati Eye Institute|