| Eligibility |
Inclusion Criteria:
- Subjects must:
1. be at least 10 years of age of either sex and any race;
2. provide written informed consent and sign a HIPAA form. Subjects who are under
the age of 18 will need to sign an assent form as well as having a parent or
legal guardian sign an informed consent;
3. be willing and able to follow all instructions and attend all study visits;
4. (If female and of childbearing potential) agree to have urine pregnancy testing
performed at visits 2, 4a (must be negative) and at exit visit (Visit 5); 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 the
first dose of investigational drug (Visit 4a) and for 1 month after the last dose
of investigational drug (Visit 5). 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 the first dose
of investigational drug (Visit 4a). 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);
5. (If male and with female partner of childbearing potential) must use at least 1
medically acceptable form of birth control. throughout the study duration, for at
least 14 days prior to the first dose of investigational drug (Visit 4a) and for
1 month after the last dose of the study drug (Visit 5) 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 the first
dose of investigational drug (Visit 4a). Without a vasectomy, must use condoms
with spermicidal foam/gel/film/cream/suppository.
6. have a history of ocular allergies and a positive skin test reaction to a
seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust
mites, cockroach) allergen as confirmed by an allergic skin test conducted at
Visit 1 or within the past 24 months;
7. have a calculated best-corrected visual acuity of 0.7 LogMar or better in each
eye as measured using an ETDRS chart at Visit 2;
8. have a positive bilateral CAC reaction (defined as having scores of = 2 for
ocular itching and = 2 for conjunctival redness) within 10 minutes of
instillation of the last titration of allergen at Visit 2;
9. have a positive bilateral CAC reaction (defined as having scores of = 2 for
ocular itching and = 2 for conjunctival redness) in at least 2 out of 3
timepoints at following the challenge at Visit 3;
10. be able and willing to discontinue wearing contact lenses for at least 72 hours
prior to Visit 2 and during the study trial period.
Exclusion Criteria:
- Subjects may not:
1. have known contraindications or sensitivities to the use of any of the
investigational product(s) or their components;
2. 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);
3. have had ocular surgical intervention within 3 months prior to enrollment (Visit
4a) and/or a history of refractive surgery within 6 months prior to enrollment
(Visit 4a);
4. have a known history of retinal detachment, diabetic retinopathy, or progressive
retinal disease;
5. have the presence of an active ocular infection (bacterial, viral or fungal),
positive history of an ocular herpetic infection, or preauricular lymphadenopathy
at any visit;
6. manifest signs or symptoms of clinically active allergic conjunctivitis in either
eye at the start of Visits 2, 3, or 4a (defined as a score of >0 for itching
and/or >1 for conjunctival redness);
7. use any of the following disallowed medications during the period indicated prior
to Visit 2 and agree not to use disallowed medications throughout the study: 7
Days
- systemic or ocular H1 antihistamines, H1 antihistamine/mast-cell stabilizer
drug combinations, H1 antihistamine-vasoconstrictor drug combinations,
- decongestants,
- immunotherapeutic agents,
- monoamine oxidase inhibitors,
- artificial tears,
- eye whiteners (eg, vasoconstrictors),
- lid scrubs,
- mast cell stabilizers,
- prostaglandins or prostaglandin derivatives,
- ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs);
*Baby aspirin (81 mg) is allowed as long as a stable dose has been
maintained for at least 30 days prior to Visit 1 and will continue to be
maintained for the duration of the study. 14 Days
- inhaled, ocular, topical, or systemic corticosteroids or mast cell
stabilizers; 45 Days
- depo-corticosteroids 2 Months
- immunosuppressive or cancer chemotherapeutic agents Note: Currently marketed
over-the counter anti-allergy eyedrops (i.e., anti-histamine/vasoconstrictor
combination products like Visine-A® or Naphcon-A®) may be administered to
subjects at the end of each visit, after all evaluations are completed;
8. have any significant illness (for example, any autoimmune disease requiring
therapy, or severe cardiovascular disease [including arrhythmias]) the
Investigator feels could be expected to interfere with the subject's safety or
study parameters and/or put the subject at any unnecessary risk (includes but is
not limited to poorly controlled hypertension or poorly controlled diabetes, a
history of status asthmaticus, organ transplants, a known history of persistent
moderate or severe asthma, or a known history of moderate to severe allergic
asthmatic reactions to any of the study allergens);
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