Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntranasal Lacrimal Neurostimulator (Oculeve)
Neurostimulation device
Sponsors
Oculeve, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with moderate to severe dry eye disease * 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 history of application of 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 * Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulated Acute Tear Production | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corrected Distance Visual Acuity | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device-related Adverse Events | 6 months | Number of subjects who experienced any device-related adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Active - Device |
|---|---|
| Age, Customized 50 to <60 years | 25 participants |
| Age, Customized < 50 years | 15 participants |
| Age, Customized 60 to <70 years | 40 participants |
| Age, Customized ≥70 years | 17 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 97 |
| serious Total, serious adverse events | 8 / 97 |
Outcome results
Primary
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.
Population: The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active - Device | Stimulated Acute Tear Production | Stimulated Schirmer Test | 17.28 Scores on a scale | Standard Deviation 11.948 |
| Active - Device | Stimulated Acute Tear Production | Unstimulated Schirmer Test | 7.92 Scores on a scale | Standard Deviation 6.386 |
Secondary
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
Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active - Device | Corrected Distance Visual Acuity | Right Eye | -0.028 LogMAR | Standard Deviation 0.0905 |
| Active - Device | Corrected Distance Visual Acuity | Left Eye | -0.033 LogMAR | Standard Deviation 0.0809 |
Secondary
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
Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active - Device | Slit Lamp Biomicroscopy | 0 participants |
Other Pre-specified
Device-related Adverse Events
Number of subjects who experienced any device-related adverse events.
Time frame: 6 months
Population: The safety population included all subjects who received an investigational device and initiated neurostimulation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active - Device | Device-related Adverse Events | Serious device-related AEs | 0 participants |
| Active - Device | Device-related Adverse Events | Non-serious device-related AEs | 36 participants |