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The purpose of the study is to analyze the sensation to eye drops containing menthol in people with healthy eyes and in people with dry eyes. This study also examines the temperature of your eye using an Infrared Camera.
Dry eye disease (DED) has been defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface1. An estimated 25 million Americans are reported to have dry eye disease (DED)2, which is a number that will only increase with the U.S. aging population3. The only treatment currently available in the U.S. targets inflammation on the ocular surface. Because dry eye is a complicated disease that encompasses many conditions of the eye, diversified ways to treating the disease are necessary. Some recent studies suggests that some Dry Eye symptoms are caused by corneal cold thermoreceptors (such as TRPM8) chronically firing at below-normal thresholds. It thus logically follows that dry eye patients could be distinguished from normal patients by possessing higher symptom responses secondary to topical application of menthol, a potent agonist of TRPM8. If dry eye patients indeed have lower threshold firing of TRPM8, agonizing TRPM8 with menthol will elicit a more severe symptom response, given equal concentrations across populations.
To fully elucidate this relationship between TRPM8 agonists, sensation, and tear film cooling, two dry eye populations will be tested - one population which has exhibited symptom response to a previous dry eye agent, and one population with no symptom response to the same agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rohto (r) Hydra | Active Comparator | Menthol containing over the counter eyedrop |
|
| Systane (r) Ultra | Placebo Comparator | Non-Menthol containing over the counter eyedrop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rohto (r) Hydra | Drug | Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the Cooling Scale For Rohto (r) Hydra | Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool. | 4 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the Cooling Scale For Systane (r) Ultra | Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool. | 4 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Lane | Ora Clinical | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28933582 | Derived | Corcoran P, Hollander DA, Ousler GW 3rd, Angjeli E, Rimmer D, Lane K, Abelson MB. Dynamic Sensitivity of Corneal TRPM8 Receptors to Menthol Instillation in Dry Eye Versus Normal Subjects. J Ocul Pharmacol Ther. 2017 Nov;33(9):686-692. doi: 10.1089/jop.2017.0050. Epub 2017 Sep 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dry Eye Participants | Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other. |
| FG001 | Normal Participants | Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dry Eye Participants | Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other. |
| BG001 | Normal Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of the Cooling Scale For Rohto (r) Hydra | Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool. | All Participants Population- all participants who received both study treatments. | Posted | Mean | Standard Deviation | units on a scale | 4 Minutes |
|
Adverse events were collected from the signing of the informed consent form to the end of the study, approximately 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dry Eye Participants | Participants with dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Research and Development | Ora | 9786858900 | klane@oraclinical.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Systane (r) Ultra | Drug | Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose |
|
|
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Normal Participants |
Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol, in the other. |
|
|
| Secondary | Sum of the Cooling Scale For Systane (r) Ultra | Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool. | All Participants Population- all participants who received both study treatments. | Posted | Mean | Standard Deviation | units on a scale | 4 minutes |
|
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|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Normal Participants | Participants who did not have dry eye received 1 drop of menthol-containing over the counter eye drop (Rohto [r] Hydra) in one eye and 1 drop of comparator treatment (Systane [r] Ultra), which did not contain menthol. | 0 | 15 | 0 | 15 | 0 | 15 |
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