Seasonal Allergic Conjunctivitis
Conditions
Brief summary
To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
Interventions
DRUGBrimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
DRUGKetotifen fumarate ophthalmic solution 0.035%
Ketotifen fumarate ophthalmic solution 0.035%
Brimonidine tartrate ophthalmic solution 0.025%
DRUGExperimental: Vehicle ophthalmic solution
Experimental: Vehicle ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must: 1. be at least 18 years of age of either sex and any race; 2. provide written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form; 3. be willing and able to follow all instructions and attend all study visits; 4. provide proof of COVID-19 vaccination 5. be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 2 and for the duration of the visit; 6. have seasonal allergic conjunctivitis to ragweed or timothy grass documented by a self-reported history of ocular allergic symptoms for the last 2 consecutive years during the ragweed or timothy grass seasons and a positive skin test reaction to ragweed or timothy grass pollen as confirmed by the allergic skin test given at or within 24 months of the subject's Visit 1; 7. (If female and of childbearing potential) agree to have urine pregnancy testing performed at visit 2, (must be negative); must not be lactating; and must agree to use at least 1 medically acceptable form of birth control throughout the study duration, for at least 14 days prior to and 1 month after receiving investigational drug. Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject), spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of male partner at least 3 months prior to receiving investigational drug (Visit 2). Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 8. (If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control· Note: Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to receiving investigational drug (Visit 2). Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository throughout the study duration, for at least 14 days prior to and 1 month after investigational drug (Visit 2). 9. have a calculated visual acuity (VA) of 0.7 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1; 10. have a positive Allergen BioCube challenge response to pollen exposure at the 90 minute time point of ABC exposure at Visit 2, defined as bilateral score of \>2 in ocular itching and ocular redness.
Exclusion criteria
* Subjects may not: 1. have known contraindications or sensitivities to the use of any of the investigational product medication or components; 2. 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. 3. have an upper respiratory tract or sinus infection within the previous 2 weeks of Visit 1; 4. have a history of anaphylaxis or poor tolerability of previously administered allergen; 5. 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). 6. 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; 7. 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); 8. 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Symptom Score | Assessed up to 480 minutes post-instillation of assigned IP | 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. |
| Ocular Redness Measured by Ocular Itching Scale | Assessed up to 480 minutes post-instillation of assigned IP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tearing Measured by Watery Eyes Scale | up to 480 minutes post-instillation of assigned IP | 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. |
| Lid Swelling Measured by Eyelid Swelling Scale | up to 480 minutes post-instillation of assigned IP | 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 |
| Chemosis Evaluated | up to 480 minutes post-instillation of assigned IP | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each subject was randomized to receive one of the four treatments one time in both eyes
Participants by arm
| Arm | Count |
|---|---|
| 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 | 57 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% (n = 56) Ketotifen fumarate ophthalmic solution 0.035% (n = 56): Ketotifen fumarate ophthalmic solution 0.035% (n = 56) | 56 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% (n = 56) Brimonidine tartrate ophthalmic solution 0.025% (n = 56): Brimonidine tartrate ophthalmic solution 0.025% (n = 56) | 58 |
| Vehicle Ophthalmic Solution (n = 56) Experimental: Vehicle ophthalmic solution (n = 56): Experimental: Vehicle ophthalmic solution (n = 56) | 56 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 2 | 0 |
| Overall Study | Screen Failure | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (n = 56) | Ketotifen Fumarate Ophthalmic Solution 0.035% (n = 56) | Brimonidine Tartrate Ophthalmic Solution 0.025% (n = 56) | Vehicle Ophthalmic Solution (n = 56) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.5 years STANDARD_DEVIATION 15.06 | 35.0 years STANDARD_DEVIATION 12.28 | 37.1 years STANDARD_DEVIATION 16.05 | 37.1 years STANDARD_DEVIATION 16.61 | 36.2 years STANDARD_DEVIATION 15.03 |
| Age, Customized Greater or equal to 65 years | 5 Participants | 1 Participants | 3 Participants | 6 Participants | 15 Participants |
| Age, Customized Less than 65 years | 52 Participants | 55 Participants | 55 Participants | 50 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 14 Participants | 14 Participants | 15 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 42 Participants | 44 Participants | 41 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 10 Participants | 12 Participants | 10 Participants | 44 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 9 Participants | 12 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 36 Participants | 36 Participants | 34 Participants | 31 Participants | 137 Participants |
| Region of Enrollment United States | 57 Participants | 56 Participants | 58 Participants | 56 Participants | 227 Participants |
| Sex: Female, Male Female | 34 Participants | 38 Participants | 39 Participants | 39 Participants | 150 Participants |
| Sex: Female, Male Male | 23 Participants | 18 Participants | 19 Participants | 17 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 56 | 0 / 58 | 0 / 56 |
| other Total, other adverse events | 1 / 57 | 6 / 56 | 2 / 58 | 5 / 56 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 | 0 / 58 | 0 / 56 |
Outcome results
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.
Time frame: Assessed up to 480 minutes post-instillation of assigned IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 420 min Post-Instillation | 0.851 score on a scale | Standard Deviation 0.8568 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 10 min Post-Instillation | 1.807 score on a scale | Standard Deviation 1.0501 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 360 min Post-Instillation | 0.811 score on a scale | Standard Deviation 0.8599 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, Before Qualification ABC | 0.175 score on a scale | Standard Deviation 0.6031 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.728 score on a scale | Standard Deviation 0.583 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 30 min Post-Instillation | 1.443 score on a scale | Standard Deviation 0.8914 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 480 min Post-Instillation | 0.961 score on a scale | Standard Deviation 1.002 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 60 min Post-Instillation | 1.110 score on a scale | Standard Deviation 0.8737 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 30 min Post-Instillation | 1.335 score on a scale | Standard Deviation 0.8275 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 60 min Post-Instillation | 1.205 score on a scale | Standard Deviation 0.9171 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, Before Qualification ABC | 0.085 score on a scale | Standard Deviation 0.3136 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 360 min Post-Instillation | 0.723 score on a scale | Standard Deviation 0.7365 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.719 score on a scale | Standard Deviation 0.531 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 10 min Post-Instillation | 1.808 score on a scale | Standard Deviation 0.8712 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 480 min Post-Instillation | 0.777 score on a scale | Standard Deviation 0.8786 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Itching Symptom Score | Visit 2, 420 min Post-Instillation | 0.656 score on a scale | Standard Deviation 0.7348 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, Before Qualification ABC | 0.267 score on a scale | Standard Deviation 0.7549 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 10 min Post-Instillation | 1.991 score on a scale | Standard Deviation 1.0163 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.659 score on a scale | Standard Deviation 0.4581 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 30 min Post-Instillation | 1.513 score on a scale | Standard Deviation 1.0621 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 60 min Post-Instillation | 1.220 score on a scale | Standard Deviation 0.9425 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 360 min Post-Instillation | 1.125 score on a scale | Standard Deviation 0.9485 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 420 min Post-Instillation | 1.078 score on a scale | Standard Deviation 0.9461 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Itching Symptom Score | Visit 2, 480 min Post-Instillation | 1.009 score on a scale | Standard Deviation 0.9188 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 30 min Post-Instillation | 1.790 score on a scale | Standard Deviation 0.8979 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 10 min Post-Instillation | 2.022 score on a scale | Standard Deviation 0.8302 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 480 min Post-Instillation | 1.063 score on a scale | Standard Deviation 0.9011 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 420 min Post-Instillation | 0.978 score on a scale | Standard Deviation 0.8624 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.647 score on a scale | Standard Deviation 0.5174 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 60 min Post-Instillation | 1.438 score on a scale | Standard Deviation 0.772 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, Before Qualification ABC | 0.098 score on a scale | Standard Deviation 0.3493 |
| Vehicle Ophthalmic Solution | Ocular Itching Symptom Score | Visit 2, 360 min Post-Instillation | 1.089 score on a scale | Standard Deviation 1.0252 |
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.
Time frame: Assessed up to 480 minutes post-instillation of assigned IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 10 min Post-Instillation | 1.127 score on a scale | Standard Deviation 0.8253 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 480 min Post-Instillation | 1.553 score on a scale | Standard Deviation 0.8125 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 30 min Post-Instillation | 0.934 score on a scale | Standard Deviation 0.7388 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 420 min Post-Instillation | 1.456 score on a scale | Standard Deviation 0.7936 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.469 score on a scale | Standard Deviation 0.543 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, Before Qualification ABC | 1.218 score on a scale | Standard Deviation 0.5815 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 360 min Post-Instillation | 1.316 score on a scale | Standard Deviation 0.8245 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 60 min Post-Instillation | 0.904 score on a scale | Standard Deviation 0.6924 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, Before Qualification ABC | 1.327 score on a scale | Standard Deviation 0.5771 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.500 score on a scale | Standard Deviation 0.5045 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 10 min Post-Instillation | 2.116 score on a scale | Standard Deviation 0.6178 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 30 min Post-Instillation | 1.911 score on a scale | Standard Deviation 0.6421 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 60 min Post-Instillation | 1.795 score on a scale | Standard Deviation 0.7184 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 360 min Post-Instillation | 1.723 score on a scale | Standard Deviation 0.7608 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 420 min Post-Instillation | 1.759 score on a scale | Standard Deviation 0.7847 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 480 min Post-Instillation | 1.929 score on a scale | Standard Deviation 0.8471 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.642 score on a scale | Standard Deviation 0.5832 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 480 min Post-Instillation | 1.832 score on a scale | Standard Deviation 0.7757 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 420 min Post-Instillation | 1.582 score on a scale | Standard Deviation 0.6873 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 60 min Post-Instillation | 1.026 score on a scale | Standard Deviation 0.7517 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 10 min Post-Instillation | 1.293 score on a scale | Standard Deviation 0.8194 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 360 min Post-Instillation | 1.405 score on a scale | Standard Deviation 0.6896 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 30 min Post-Instillation | 1.103 score on a scale | Standard Deviation 0.7609 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Ocular Redness Measured by Ocular Itching Scale | Visit 2, Before Qualification ABC | 1.384 score on a scale | Standard Deviation 0.5815 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 30 min Post-Instillation | 2.165 score on a scale | Standard Deviation 0.7011 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 60 min Post-Instillation | 2.098 score on a scale | Standard Deviation 0.6787 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 480 min Post-Instillation | 2.063 score on a scale | Standard Deviation 0.7043 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 360 min Post-Instillation | 1.955 score on a scale | Standard Deviation 0.6416 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, Before Qualification ABC | 1.268 score on a scale | Standard Deviation 0.6464 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 10 min Post-Instillation | 2.268 score on a scale | Standard Deviation 0.6195 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 420 min Post-Instillation | 1.933 score on a scale | Standard Deviation 0.644 |
| Vehicle Ophthalmic Solution | Ocular Redness Measured by Ocular Itching Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 2.478 score on a scale | Standard Deviation 0.4984 |
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.
Time frame: up to 480 minutes post-instillation of assigned IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 10 min Post-Instillation change from baseline | -0.070 score on a scale | Standard Deviation 0.3196 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 480 min Post-Instillation | 0.088 score on a scale | Standard Deviation 0.3006 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 60 min Post-Instillation | 0.154 score on a scale | Standard Deviation 0.5298 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 30 min Post-Instillation change from baseline | -0.140 score on a scale | Standard Deviation 0.4092 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 30 min Post-Instillation | 0.158 score on a scale | Standard Deviation 0.5274 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 420 min Post-Instillation change from baseline | -0.193 score on a scale | Standard Deviation 0.5408 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.298 score on a scale | Standard Deviation 0.7249 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 420 min Post-Instillation | 0.105 score on a scale | Standard Deviation 0.3502 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, Before Qualification ABC | 0.000 score on a scale | Standard Deviation 0 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 360 min Post-Instillation change from baseline | -0.184 score on a scale | Standard Deviation 0.5561 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 10 min Post-Instillation | 0.228 score on a scale | Standard Deviation 0.583 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 480 min Post-Instillation change from baseline | -0.211 score on a scale | Standard Deviation 0.5505 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 360 min Post-Instillation | 0.114 score on a scale | Standard Deviation 0.3662 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Chemosis Evaluated | Visit 2, 60 min Post-Instillation change from baseline | -0.145 score on a scale | Standard Deviation 0.4405 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 420 min Post-Instillation | 0.067 score on a scale | Standard Deviation 0.205 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, Before Qualification ABC | 0.000 score on a scale | Standard Deviation 0 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.143 score on a scale | Standard Deviation 0.3626 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 10 min Post-Instillation | 0.121 score on a scale | Standard Deviation 0.3371 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 10 min Post-Instillation change from baseline | -0.022 score on a scale | Standard Deviation 0.249 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 30 min Post-Instillation | 0.094 score on a scale | Standard Deviation 0.311 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 30 min Post-Instillation change from baseline | -0.049 score on a scale | Standard Deviation 0.2877 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 60 min Post-Instillation | 0.094 score on a scale | Standard Deviation 0.2883 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 60 min Post-Instillation change from baseline | -0.049 score on a scale | Standard Deviation 0.245 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 360 min Post-Instillation | 0.094 score on a scale | Standard Deviation 0.296 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 360 min Post-Instillation change from baseline | -0.049 score on a scale | Standard Deviation 0.3706 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 420 min Post-Instillation change from baseline | -0.076 score on a scale | Standard Deviation 0.2564 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 480 min Post-Instillation | 0.076 score on a scale | Standard Deviation 0.2232 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Chemosis Evaluated | Visit 2, 480 min Post-Instillation change from baseline | -0.067 score on a scale | Standard Deviation 0.2919 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 480 min Post-Instillation change from baseline | -0.043 score on a scale | Standard Deviation 0.2815 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 480 min Post-Instillation | 0.091 score on a scale | Standard Deviation 0.2678 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 60 min Post-Instillation change from baseline | -0.082 score on a scale | Standard Deviation 0.2406 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 10 min Post-Instillation | 0.086 score on a scale | Standard Deviation 0.2502 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 360 min Post-Instillation | 0.069 score on a scale | Standard Deviation 0.2556 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 360 min Post-Instillation change from baseline | -0.065 score on a scale | Standard Deviation 0.2321 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.134 score on a scale | Standard Deviation 0.3811 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 420 min Post-Instillation | 0.082 score on a scale | Standard Deviation 0.2624 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 420 min Post-Instillation change from baseline | -0.052 score on a scale | Standard Deviation 0.2555 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 30 min Post-Instillation | 0.039 score on a scale | Standard Deviation 0.1609 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, Before Qualification ABC | 0.004 score on a scale | Standard Deviation 0.0328 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 30 min Post-Instillation change from baseline | -0.095 score on a scale | Standard Deviation 0.2683 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 10 min Post-Instillation change from baseline | -0.047 score on a scale | Standard Deviation 0.1957 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Chemosis Evaluated | Visit 2, 60 min Post-Instillation | 0.052 score on a scale | Standard Deviation 0.1973 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 30 min Post-Instillation | 0.134 score on a scale | Standard Deviation 0.429 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 60 min Post-Instillation | 0.112 score on a scale | Standard Deviation 0.3597 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 10 min Post-Instillation | 0.156 score on a scale | Standard Deviation 0.4537 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 420 min Post-Instillation | 0.076 score on a scale | Standard Deviation 0.2608 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, Before Qualification ABC | 0.022 score on a scale | Standard Deviation 0.1372 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 60 min Post-Instillation change from baseline | -0.018 score on a scale | Standard Deviation 0.4764 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 480 min Post-Instillation change from baseline | -0.071 score on a scale | Standard Deviation 0.449 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 480 min Post-Instillation | 0.058 score on a scale | Standard Deviation 0.2184 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 10 min Post-Instillation change from baseline | 0.027 score on a scale | Standard Deviation 0.3804 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 360 min Post-Instillation | 0.089 score on a scale | Standard Deviation 0.2756 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.129 score on a scale | Standard Deviation 0.3843 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 360 min Post-Instillation change from baseline | -0.040 score on a scale | Standard Deviation 0.4258 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 420 min Post-Instillation change from baseline | -0.054 score on a scale | Standard Deviation 0.4439 |
| Vehicle Ophthalmic Solution | Chemosis Evaluated | Visit 2, 30 min Post-Instillation change from baseline | 0.004 score on a scale | Standard Deviation 0.5319 |
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
Time frame: up to 480 minutes post-instillation of assigned IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation change from baseline | -0.18 score on a scale | Standard Deviation 0.748 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation | 0.85 score on a scale | Standard Deviation 0.973 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.04 score on a scale | Standard Deviation 0.972 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation | 0.55 score on a scale | Standard Deviation 0.777 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation | 0.75 score on a scale | Standard Deviation 0.851 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.48 score on a scale | Standard Deviation 0.802 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.55 score on a scale | Standard Deviation 0.817 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.28 score on a scale | Standard Deviation 0.851 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation | 0.60 score on a scale | Standard Deviation 0.832 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, Before Qualification ABC | 0.09 score on a scale | Standard Deviation 0.434 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.44 score on a scale | Standard Deviation 0.921 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation | 0.65 score on a scale | Standard Deviation 0.802 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation | 0.48 score on a scale | Standard Deviation 0.762 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.39 score on a scale | Standard Deviation 0.835 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, Before Qualification ABC | 0.00 score on a scale | Standard Deviation 0 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.05 score on a scale | Standard Deviation 0.644 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation | 0.43 score on a scale | Standard Deviation 0.817 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.27 score on a scale | Standard Deviation 0.707 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation | 0.77 score on a scale | Standard Deviation 0.874 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.28 score on a scale | Standard Deviation 0.75 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation | 0.42 score on a scale | Standard Deviation 0.731 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation change from baseline | 0.07 score on a scale | Standard Deviation 0.606 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation | 0.75 score on a scale | Standard Deviation 0.905 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.26 score on a scale | Standard Deviation 0.681 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation change from baseline | 0.05 score on a scale | Standard Deviation 0.644 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.70 score on a scale | Standard Deviation 0.883 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation | 0.64 score on a scale | Standard Deviation 0.841 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation | 0.44 score on a scale | Standard Deviation 0.695 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.50 score on a scale | Standard Deviation 0.827 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, Before Qualification ABC | 0.11 score on a scale | Standard Deviation 0.409 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.05 score on a scale | Standard Deviation 0.921 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation | 1.03 score on a scale | Standard Deviation 0.957 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation | 0.72 score on a scale | Standard Deviation 0.75 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation change from baseline | -0.03 score on a scale | Standard Deviation 0.652 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.34 score on a scale | Standard Deviation 0.74 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation | 0.59 score on a scale | Standard Deviation 0.744 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.47 score on a scale | Standard Deviation 0.805 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation | 0.61 score on a scale | Standard Deviation 0.864 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.44 score on a scale | Standard Deviation 0.869 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation | 0.61 score on a scale | Standard Deviation 0.838 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.44 score on a scale | Standard Deviation 0.822 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation | 0.55 score on a scale | Standard Deviation 0.826 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation | 0.81 score on a scale | Standard Deviation 0.902 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 0.92 score on a scale | Standard Deviation 0.873 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation | 0.61 score on a scale | Standard Deviation 0.824 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.02 score on a scale | Standard Deviation 0.798 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 30 min Post-Instillation | 0.90 score on a scale | Standard Deviation 0.881 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, Before Qualification ABC | 0.04 score on a scale | Standard Deviation 0.187 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.31 score on a scale | Standard Deviation 0.877 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation change from baseline | 0.06 score on a scale | Standard Deviation 0.714 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 10 min Post-Instillation | 0.98 score on a scale | Standard Deviation 0.904 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.34 score on a scale | Standard Deviation 0.895 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation | 0.67 score on a scale | Standard Deviation 0.886 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 480 min Post-Instillation | 0.58 score on a scale | Standard Deviation 0.857 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.25 score on a scale | Standard Deviation 0.929 |
| Vehicle Ophthalmic Solution | Lid Swelling Measured by Eyelid Swelling Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.11 score on a scale | Standard Deviation 0.785 |
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.
Time frame: up to 480 minutes post-instillation of assigned IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation | 0.77 score on a scale | Standard Deviation 0.835 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation change from baseline | -0.13 score on a scale | Standard Deviation 0.961 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation | 0.54 score on a scale | Standard Deviation 0.761 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation | 0.66 score on a scale | Standard Deviation 0.757 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, Before Qualification ABC | 0.12 score on a scale | Standard Deviation 0.503 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.84 score on a scale | Standard Deviation 1.123 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.57 score on a scale | Standard Deviation 1.006 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation | 0.50 score on a scale | Standard Deviation 0.726 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation | 0.42 score on a scale | Standard Deviation 0.667 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.34 score on a scale | Standard Deviation 1.192 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.81 score on a scale | Standard Deviation 1.097 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.92 score on a scale | Standard Deviation 1.113 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.68 score on a scale | Standard Deviation 0.989 |
| Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation | 1.21 score on a scale | Standard Deviation 1.056 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, Before Qualification ABC | 0.04 score on a scale | Standard Deviation 0.197 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation | 0.34 score on a scale | Standard Deviation 0.581 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.89 score on a scale | Standard Deviation 0.857 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation | 0.27 score on a scale | Standard Deviation 0.539 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.96 score on a scale | Standard Deviation 0.83 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation | 1.10 score on a scale | Standard Deviation 0.988 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation change from baseline | -0.13 score on a scale | Standard Deviation 0.839 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation | 0.79 score on a scale | Standard Deviation 0.883 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.44 score on a scale | Standard Deviation 0.826 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation | 0.65 score on a scale | Standard Deviation 0.909 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.58 score on a scale | Standard Deviation 1.048 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation | 0.41 score on a scale | Standard Deviation 0.668 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.23 score on a scale | Standard Deviation 0.977 |
| Ketotifen Fumarate Ophthalmic Solution 0.035% | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.82 score on a scale | Standard Deviation 0.811 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation | 0.73 score on a scale | Standard Deviation 0.865 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation | 0.68 score on a scale | Standard Deviation 0.945 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.84 score on a scale | Standard Deviation 1.056 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.72 score on a scale | Standard Deviation 1.085 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.67 score on a scale | Standard Deviation 1.024 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation | 1.16 score on a scale | Standard Deviation 1.056 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation | 0.56 score on a scale | Standard Deviation 0.72 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.41 score on a scale | Standard Deviation 1.219 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation | 0.94 score on a scale | Standard Deviation 0.937 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation | 0.64 score on a scale | Standard Deviation 0.883 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.47 score on a scale | Standard Deviation 0.991 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, Before Qualification ABC | 0.22 score on a scale | Standard Deviation 0.773 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation change from baseline | -0.25 score on a scale | Standard Deviation 0.768 |
| Brimonidine Tartrate Ophthalmic Solution 0.025% | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.77 score on a scale | Standard Deviation 1.035 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation change from baseline | -0.63 score on a scale | Standard Deviation 1.102 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, Before Qualification ABC | 0.13 score on a scale | Standard Deviation 0.429 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 90 Minutes during Qualification ABC (Baseline) | 1.10 score on a scale | Standard Deviation 0.997 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation | 1.14 score on a scale | Standard Deviation 0.971 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 10 min Post-Instillation change from baseline | 0.04 score on a scale | Standard Deviation 0.945 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation | 0.98 score on a scale | Standard Deviation 0.958 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 30 min Post-Instillation change from baseline | -0.12 score on a scale | Standard Deviation 0.853 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation | 0.76 score on a scale | Standard Deviation 0.879 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 60 min Post-Instillation change from baseline | -0.34 score on a scale | Standard Deviation 0.944 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation | 0.65 score on a scale | Standard Deviation 0.744 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 360 min Post-Instillation change from baseline | -0.45 score on a scale | Standard Deviation 1.03 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation | 0.46 score on a scale | Standard Deviation 0.582 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 420 min Post-Instillation change from baseline | -0.64 score on a scale | Standard Deviation 1.065 |
| Vehicle Ophthalmic Solution | Tearing Measured by Watery Eyes Scale | Visit 2, 480 min Post-Instillation | 0.46 score on a scale | Standard Deviation 0.785 |