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This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KetoNaph | Experimental | KetoNaph Ophthalmic Solution |
|
| Vehicle | Placebo Comparator | Vehicle of KetoNaph Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KetoNaph | Drug | Ophthalmic Solution administered BID for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Adverse Event. | An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article. | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuyen Ong, MD | Bausch & Lomb Incorporated | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | KetoNaph | KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks |
| FG001 | Vehicle | Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KetoNaph | KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks |
| BG001 | Vehicle | Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks |
| 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 | Percentage of Participants With at Least One Adverse Event. | An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article. | Posted | Count of Participants | Participants | 42 days |
|
42 days
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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 | KetoNaph | KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.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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| Vehicle |
| Drug |
Vehicle of KetoNaph ophthalmic solution administered bid for six weeks |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 357 |
| 20 |
| 357 |
| EG001 | Vehicle | Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks | 1 | 177 | 1 | 177 |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Drug abuse | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA (12.1) | Non-systematic Assessment |
|
Please contact sponsor directly for details.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |