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The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elestat | Experimental |
| |
| Pataday | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elestat | Drug | Elestat BID for 2 days |
| |
| Pataday |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Itch Score From Baseline | Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes. | 0 hours, 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Comfort Score at 12 Hours | Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Raizman, MD | Ophthalmic Consultants of Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elestat | 1 drop each eye for 2 days |
| FG001 | Pataday | 1 drop each eye for 1 day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elestat | 1 drop each eye for 2 days |
| BG001 | Pataday | 1 drop each eye for 1 day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Ocular Itch Score From Baseline | Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes. | Posted | Mean | Standard Deviation | units on a scale | 0 hours, 12 hours |
|
|
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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 | Elestat | 1 drop each eye for 2 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | clinicaltrialsdisclosure@merck.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C053090 | epinastine |
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Pataday QD for 2 days |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Ocular Comfort Score at 12 Hours | Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. | Posted | Mean | Standard Deviation | units on a scale | 12 hours |
|
|
|
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Pataday | 1 drop each eye for 1 day | 0 | 0 | 0 | 0 |
PI cannot publish or discuss trial results until written communication is received from Inspire.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |