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To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Experimental | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
|
| Ketotifen fumarate ophthalmic solution 0.035% | Experimental | Ketotifen fumarate ophthalmic solution 0.035% |
|
| Brimonidine tartrate ophthalmic solution 0.025% | Experimental | Brimonidine tartrate ophthalmic solution 0.025% |
|
| Vehicle ophthalmic solution | Experimental | Vehicle ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Drug | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching Symptom Score | Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome. | Assessed up to 480 minutes post-instillation of assigned IP |
| Ocular Redness Measured by Ocular Itching Scale | Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome. | Assessed up to 480 minutes post-instillation of assigned IP |
| Measure | Description | Time Frame |
|---|---|---|
| Tearing Measured by Watery Eyes Scale | Tearing evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, NOT allowing half unit increments), with 4 being the worse outcome. | up to 480 minutes post-instillation of assigned IP |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subjects may not:
have known contraindications or sensitivities to the use of any of the investigational product medication or components;
have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood, and Lung Institute classification (with the exception of exercise induced asthma).
Note: Subjects with fall induced asthma that is either mild persistent (defined as >1 per week, but <1 per day), moderate persistent, or severe persistent will be excluded.
have an upper respiratory tract or sinus infection within the previous 2 weeks of Visit 1;
have a history of anaphylaxis or poor tolerability of previously administered allergen;
have a compromised lung function at Visit 1 (defined as a peak expiratory flow rate [PEFR] that is below 80% of the predicted average PEFR, as calculated by gender, age, and measured height from the Mini-Wright instruction's table: Normal Adult Predicted Average Peak Expiratory Flow).
have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit 1;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye);
have had ocular surgical intervention within three months prior to Visit 1, or during the trial or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 104 Butchertown Clinical Trials | Louisville | Kentucky | 40206 | United States | ||
| 101 Andover Eye Associates |
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Each subject was randomized to receive one of the four treatments one time in both eyes
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
| FG001 | Ketotifen Fumarate Ophthalmic Solution 0.035% |
| 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 | Yes | No | No | Study Protocol | Jul 31, 2023 | Dec 5, 2024 |
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| Ketotifen fumarate ophthalmic solution 0.035% | Drug | Ketotifen fumarate ophthalmic solution 0.035% |
|
| Brimonidine tartrate ophthalmic solution 0.025% | Drug | Brimonidine tartrate ophthalmic solution 0.025% |
|
| Experimental: Vehicle ophthalmic solution | Drug | Experimental: Vehicle ophthalmic solution |
|
| Lid Swelling Measured by Eyelid Swelling Scale |
Lid swelling evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome |
| up to 480 minutes post-instillation of assigned IP |
| Chemosis Evaluated | Chemosis evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome. | up to 480 minutes post-instillation of assigned IP |
| Andover |
| Massachusetts |
| 01810 |
| United States |
| 105 - Advancing Vision Research | Goodlettsville | Tennessee | 37072 | United States |
| 102 Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| 108 Emerson Clinical Research Institute Inc. | Falls Church | Virginia | 22046 | United States |
| 107 Virginia Eye Institute | Richmond | Virginia | 23230 | United States |
Ketotifen fumarate ophthalmic solution 0.035%
| FG002 | Brimonidine Tartrate Ophthalmic Solution 0.025% | Brimonidine tartrate ophthalmic solution 0.025% |
| FG003 | Vehicle Ophthalmic Solution | Experimental: Vehicle ophthalmic solution |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (n = 56) | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution |
| BG001 | Ketotifen Fumarate Ophthalmic Solution 0.035% (n = 56) | Ketotifen fumarate ophthalmic solution 0.035% (n = 56): Ketotifen fumarate ophthalmic solution 0.035% (n = 56) |
| BG002 | Brimonidine Tartrate Ophthalmic Solution 0.025% (n = 56) | Brimonidine tartrate ophthalmic solution 0.025% (n = 56): Brimonidine tartrate ophthalmic solution 0.025% (n = 56) |
| BG003 | Vehicle Ophthalmic Solution (n = 56) | Experimental: Vehicle ophthalmic solution (n = 56): Experimental: Vehicle ophthalmic solution (n = 56) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 Symptom Score | Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Assessed up to 480 minutes post-instillation of assigned IP |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Ocular Redness Measured by Ocular Itching Scale | Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Assessed up to 480 minutes post-instillation of assigned IP |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Tearing Measured by Watery Eyes Scale | Tearing evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, NOT allowing half unit increments), with 4 being the worse outcome. | Posted | Mean | Standard Deviation | score on a scale | up to 480 minutes post-instillation of assigned IP |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Lid Swelling Measured by Eyelid Swelling Scale | Lid swelling evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome | Posted | Mean | Standard Deviation | score on a scale | up to 480 minutes post-instillation of assigned IP |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Chemosis Evaluated | Chemosis evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome. | Posted | Mean | Standard Deviation | score on a scale | up to 480 minutes post-instillation of assigned IP |
|
Assessed for approximately 8 hours after treatment
Ocular Adverse events were reported at the participant level
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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 | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | 0 | 57 | 0 | 57 | 1 | 57 |
| EG001 | Ketotifen Fumarate Ophthalmic Solution 0.035% | Ketotifen fumarate ophthalmic solution 0.035% | 0 | 56 | 0 | 56 | 6 | 56 |
| EG002 | Brimonidine Tartrate Ophthalmic Solution 0.025% | Brimonidine tartrate ophthalmic solution 0.025% | 0 | 58 | 0 | 58 | 2 | 58 |
| EG003 | Vehicle Ophthalmic Solution | Experimental: Vehicle ophthalmic solution | 0 | 56 | 0 | 56 | 5 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
| ||
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
| ||
| Eyelid exfoliation | Eye disorders | Non-systematic Assessment |
| ||
| Erythema of eyelid | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctival oedema | Eye disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | 5853385306 | Daniel.Donatello@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2023 | Dec 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D007665 | Ketotifen |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Greater or equal to 65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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 |
|
| Unknown or Not Reported |
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| Visit 2, 90 Minutes during Qualification ABC (Baseline) |
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| Visit 2, 10 min Post-Instillation |
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| Visit 2, 30 min Post-Instillation |
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| Visit 2, 60 min Post-Instillation |
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| Visit 2, 360 min Post-Instillation |
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| Visit 2, 420 min Post-Instillation |
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| Visit 2, 480 min Post-Instillation |
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