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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM-100 | Experimental | One drop of EM-100 in either the right or left eye once on Day 1. |
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| Zaditor® | Experimental | One drop of Zaditor® in either the right or left eye once on Day 1. |
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| Vehicle | Experimental | One drop of Vehicle in either the right or left eye once on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EM-100 | Drug | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub. | 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness | The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
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There were 65 participants enrolled (130 eyes). 38 participants received EM-100 in one eye and Zaditor in the other eye. 13 participants received EM-100 in one eye and vehicle in the other eye. 14 participants received Zaditor in one eye and vehicle in the other eye. Thus, of 65 participants, 51 received EM-100 in one of their eyes, 52 received Zaditor in one of their eyes, and 27 received vehicle in one of their eyes. Each participant received 2 of the 3 study treatments, one in each eye.
| ID | Title | Description |
|---|---|---|
| FG000 | EM-100 | One drop of EM-100 in either the right or left eye once on Day 1. EM-100: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
| FG001 | Zaditor® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2018 |
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| Zaditor® | Drug | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
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| Vehicle | Drug | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
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| 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 |
One drop of Zaditor® in either the right or left eye once on Day 1.
Zaditor®: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
| FG002 | Vehicle | One drop of Vehicle in either the right or left eye once on Day 1. Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye). Demographic data were not collected by treatment or by eye. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Iris color | Count of Participants | Participants |
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| 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 | Ocular Itching | Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub. | The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye). | Posted | Mean | Standard Deviation | score on a scale | 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 | eyes | eyes |
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| Secondary | Conjunctival Redness | The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed). | The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 different treatments, one in each eye). | Posted | Mean | Standard Deviation | score on a scale | 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1 |
|
1 day
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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 | Overall Participants | The 65 enrolled participants had one of the three study treatments instilled in each eye (each subject had 2 of the 3 different treatments, one in each eye). | 0 | 65 | 0 | 65 | 0 | 65 |
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Please contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heleen DeCory | Bausch & Lomb | (585) 338-8161 | heleen.decory@bausch.com |
| Mar 27, 2023 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C514418 | ketotifen fumarate ophthalmic solution |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hazel |
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| Green |
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| 7 minutes post CAC |
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| OG002 |
| Vehicle |
One drop of Vehicle in either the right or left eye once on Day 1. Vehicle: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
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