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The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketotifen/naphazoline | Experimental | Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
|
| Vehicle | Placebo Comparator | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
|
| Naphazoline | Active Comparator | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
|
| Ketotifen | Active Comparator | Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketotifen/naphazoline | Drug | One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching | Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub | 3, 5, and 7 minutes post challenge at 14 days |
| Conjunctival Redness | Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ciliary Redness | Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days |
| Episcleral Redness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Trusso | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Consultants, Inc. | North Andover | Massachusetts | 01845 | United States |
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There were 70 eyes in the KetoNaph group, 72 in the ketotifen group, 70 in the naphazoline group, and 70 in the vehicle group, for a total of 282 eyes (141 subjects).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketotifen/Naphazoline | Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. |
| FG001 | Ketotifen | Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. |
| FG002 | Naphazoline | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. |
| FG003 | Vehicle | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketotifen/Naphazoline | Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. |
| BG001 |
| 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 | Ocular Itching | Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub | The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment. | Posted | Mean | Standard Deviation | score on a scale | 3, 5, and 7 minutes post challenge at 14 days | eyes | eyes |
|
14 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 | Ketotifen/Naphazoline | Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. |
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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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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| D009278 | Naphazoline |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
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| Naphazoline | Drug | One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. |
|
| Ketotifen | Drug | One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. |
|
| Vehicle | Drug | One drop of vehicle ophthalmic solution at visit 3 and visit 4. |
|
Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. |
| 7, 15, and 20 minutes post challenge at 14 days |
| Chemosis | Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days |
| Eyelid Swelling | Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe. | 7, 15, and 20 minutes post challenge at 14 days |
| Percentage of Eyes With hTearing | Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present. | 7, 15, and 20 minutes post challenge at 14 days |
| Percentage of Eyes With Ocular Mucus Discharge | Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present. | 7, 15, and 20 minutes post challenge at 14 days |
| Ketotifen |
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. |
| BG002 | Naphazoline | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. |
| BG003 | Vehicle | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Ketotifen | Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. |
| OG002 | Naphazoline | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. |
| OG003 | Vehicle | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4. |
|
|
| Primary | Conjunctival Redness | Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment. | Posted | Mean | Standard Deviation | score on a scale | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Ciliary Redness | Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Mean | Standard Deviation | score on a scale | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Episcleral Redness | Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Mean | Standard Deviation | score on a scale | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Chemosis | Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Mean | Standard Deviation | score on a scale | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Eyelid Swelling | Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Mean | Standard Error | score on a scale | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes With hTearing | Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Count of Units | eyes | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes With Ocular Mucus Discharge | Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present. | This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment. | Posted | Count of Units | eyes | 7, 15, and 20 minutes post challenge at 14 days | eyes | eyes |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Ketotifen | Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. | 0 | 36 | 0 | 36 |
| EG002 | Naphazoline | Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. | 0 | 35 | 0 | 35 |
| EG003 | Vehicle | Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4. | 0 | 35 | 0 | 35 |
Contact sponsor directly for details.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
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