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Difficulty in enrollment of study participants
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| Name | Class |
|---|---|
| CooperVision, Inc. | INDUSTRY |
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To find out if the use of an intranasal tear neurostimulator (ITN), may be useful in decreasing the pain symptoms felt by patients who experience contact lens discomfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TrueTearâ„¢ intranasal neurostimulator (ITN) Active Arm | Active Comparator | TrueTearâ„¢ intranasal neurostimulator (ITN) with active tips - The tips carry the current from the base to the nasociliary nerve. |
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| TrueTearâ„¢ intranasal neurostimulator (ITN) Placebo/Sham Arm | Placebo Comparator | TrueTearâ„¢ intranasal neurostimulator (ITN) with sham tips - The "sham" tips and do not properly carry the current. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTearâ„¢ intranasal neurostimulator (ITN) | Device | The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN "active" arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN "sham" arm will receive tips without the current. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the decrease in microneuromas by means of in vivo confocal microscopy (IVCM) among CLD subjects following treatment | 3 months | |
| To measure the changes in the level of discomfort/pain after instillation of hyperosmolarity drops among CLD subjects following treatment | 3 months | |
| To measure changes in Contact Lens Dry Eye Questionnaire (CLDEQ)-8 among CLD subjects using ITN. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To access the corneal dendritic cells (DC) density by means of IVCM among CLD subjects before and after treatment. | 3 months | |
| To evaluate the change in wearing time and comfortable wearing time from baseline to the final visit. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Use of topical drops other than artificial tear substitutes
Ocular surgery or other ocular disease within 3 months prior to study enrollment
Concurrent ocular disease that may impact results
Have dry eye (as defined by 2 or more of the parameters below)
NEI scale corneal staining of 4 out of 15 at the time of enrollment
Improper CL fit
No microneuroma by in vivo confocal microscopy
Overnight wear within 1 month of screening visit
Use of colored or cosmetic lenses
Contra-indication to ITN
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |