Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis

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 Portabilityand 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 hoursprior to Visit 2 and for the duration of the visit;

6. have seasonal allergic conjunctivitis to ragweed or timothy grass documented bya self-reported history of ocular allergic symptoms for the last 2 consecutiveyears during the ragweed or timothy grass seasons and a positive skin testreaction to ragweed or timothy grass pollen as confirmed by the allergic skintest given at or within 24 months of the subject's Visit 1;

7. (If female and of childbearing potential) agree to have urine pregnancy testingperformed at visit 2, (must be negative); must not be lactating; and must agreeto use at least 1 medically acceptable form of birth control throughout thestudy duration, for at least 14 days prior to and 1 month after receivinginvestigational 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 methodof contraception, transdermal contraceptive, intrauterine device, or surgicalsterilization of male partner at least 3 months prior to receivinginvestigational drug (Visit 2). Note: Women considered capable of becomingpregnant include all females who have experienced menarche and have notexperienced menopause (as defined by amenorrhea for greater than 12 consecutivemonths) 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 1medically acceptable form of birth control· Note: Acceptable forms of birthcontrol are true abstinence (when this is in line with the preferred and usuallifestyle of the subject) or vasectomy at least 3 months prior to receivinginvestigational drug (Visit 2). Without a vasectomy, must use condoms withspermicidal foam/gel/film/cream/suppository throughout the study duration, forat 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 asmeasured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart atVisit 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 theinvestigational product medication or components;

2. have a history of mild persistent, moderate or severe asthma within thepreceding 5 years according to the National Heart, Blood, and Lung Instituteclassification (with the exception of exercise induced asthma).Note: Subjects with fall induced asthma that is either mild persistent (definedas >1 per week, but <1 per day), moderate persistent, or severe persistent willbe excluded.

3. have an upper respiratory tract or sinus infection within the previous 2 weeksof Visit 1;

4. have a history of anaphylaxis or poor tolerability of previously administeredallergen;

5. have a compromised lung function at Visit 1 (defined as a peak expiratory flowrate [PEFR] that is below 80% of the predicted average PEFR, as calculated bygender, 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) measuredin mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit 1;

7. have any ocular condition that, in the opinion of the investigator, couldaffect the subject's safety or trial parameters (including but not limited tonarrow angle glaucoma, clinically significant blepharitis, follicularconjunctivitis, iritis, pterygium, or a diagnosis of dry eye);

8. have had ocular surgical intervention within three months prior to Visit 1, orduring 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 daysafter;