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This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relestat Ophthalmic Solution 0.05% | Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relestat Ophthalmic Solution 0.05% | Drug | Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Reporting Adverse Events | An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Up to 10 Months |
| Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement. | Baseline, 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangwon-do | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Relestat Ophthalmic Solution 0.05% | Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety Assessment Population which included all patients who completed the study, was used for the analysis of baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Relestat Ophthalmic Solution 0.05% | Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Patients Reporting Adverse Events | An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Safety Assessment Population: included all patients who completed the study. | Posted | Number | Percentage of Patients | Up to 10 Months |
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Adverse events were collected during follow-up, for a period of up to 10 months.
The Safety Assessment Population was used to assess adverse events (AEs) and serious adverse events (SAE). The Safety Assessment Population included all patients who completed the study.
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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 | Relestat Ophthalmic Solution 0.05% | Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President GSE, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.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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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement. | Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, 2 Weeks |
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| 0 |
| 745 |
| 0 |
| 745 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |