| Eligibility |
Inclusion Criteria:
1. be at least 5 years of age at Screening Visit or Visit 1 (if Screening and Visit 1 are
done on the same day), of either sex and any race (a government issued ID and/or birth
certificate will be verified at the time ICF is signed);
2. provide written informed consent and sign the HIPAA form. Subjects who are at least 7
years of age and less than 18 years of age will need to sign an assent form. In
addition, all subjects below the age of 18 years will be required to have both parents
or legal guardian sign the informed consent.
3. be willing and able to follow all instructions and attend all study visits (and be
accompanied by a parent/legal guardian if the subject is under the age of 18);
4. be able to self-administer eye drops satisfactorily or have a caregiver or
parent/legal guardian (if applicable, for subjects less than 18 years of age) at home1
routinely available for this purpose.
5. for subjects less than 18 years of age, have either a history or family history of
atopic disease (such as atopic dermatitis, asthma, allergic conjunctivitis/rhinitis,
and atopic keratoconjunctivitis).
6. (if female and of childbearing potential) agree to have urine pregnancy testing
performed at Visit 1 (must be negative) and at exit visit2
; must not be lactating; and must agree to use at least 1 medically acceptable form of
birth control throughout the study duration and for at least 14 days prior to Visit 1
and 1 month after discontinuing investigational product. 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 1). 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).
7. (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 product
(Visit 1). 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 discontinuing investigational product;
8. have ocular health within normal limits, including a calculated visual acuity of 0.3
logMAR or better in each eye as measured using an ETDRS chart. For subjects under 10
years old who are developmentally unable to use the ETDRS chart, a best attempt at
visual acuity will be made using the LEA symbols or Visual Behavior. For subjects
utilizing LEA symbols, Snellen equivalent units of 20/63 or better in both eyes will
be required. Subjects utilizing Visual Behavior must have a passing score;
9. (for selected healthy adult subjects agreeing to undergo PK blood draws) have a body
mass index (BMI) =18 and =34 lbs/in2 and a minimum body weight of 99 lbs;
10. (for selected healthy adult subjects agreeing to undergo PK blood draws) have suitable
venous access for blood sampling.
Exclusion Criteria:
1. have known contraindications or sensitivities to the use of any of the investigational
product medication or components;
2. have had ocular surgical intervention within 3 months prior to Visit 1 or during the
study and/or a history of refractive surgery within the past 6 months;
3. have a known history of retinal detachment, diabetic retinopathy, or active retinal
disease;
4. have the presence of an active ocular infection (bacterial, viral or fungal) or
positive history of an ocular herpetic infection at any visit;
5. use any of the following disallowed medications during the period indicated prior to
Visit 1 and during the study: 5 days
- artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular
decongestants, ocular corticosteroids, ocular antihistamines, and any other
topical ophthalmic agents;
- contact lenses;
- systemic and nasal antihistamines or decongestants. 14 days
- systemic corticosteroids or cancer chemotherapy, and/or any other systemic
medications which the investigator feels may confound study data, or interfere
with subject's study participation; The following medications are not allowed
before entry into the study and for the duration of the study. However, if
subject's PCP has taken that subject off any of the following medications =4
weeks prior to the first dose of investigational drug (Visit 1), that subject may
be enrolled:
- monoamine oxidase (MAO) inhibitors;
- antidepressants that affect the noradrenergic transmission such as tricyclic and
tetracyclic antidepressants.
6. have prior (within 7 days of beginning investigational product) or currently active
significant illness that could compromise participation, in the opinion of the
investigator;
7. have prior (within 30 days of beginning investigational product) or anticipated
concurrent use of an investigational product or device during the study period;
8. have been randomized in study 909 or 910 conducted by Bausch & Lomb;
9. be an employee or family member of employee at the investigative site;
10. have an ocular or systemic condition or is in a situation that the investigator feels
may put the subject at significant risk, may confound the study results, or may
interfere significantly with the subject's study participation;
11. have planned surgery (ocular or systemic) during the trial period or within 30 days
after;
12. have body weight below the 5th percentile for their age (subjects 12 years of age or
younger only) (see Appendix 2);
13. be a female who is currently pregnant, is planning a pregnancy, or lactating;
14. have an abnormal blood pressure (defined as = 90 or = 160 (systolic) measured in mmHg
or = 60 or = 100 (diastolic) measured in mmHg). For pediatric subjects, abnormal blood
pressure is defined as = 140 (systolic) measured in mmHg or = 90 (diastolic) measured
in mmHg;
15. have an intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or
have a normal IOP with a prior diagnosis/history of glaucoma at Visit 1;
16. have symptoms associated with COVID-19 or have been in contact with someone diagnosed
with COVID-19 within 14 days of the Screening Visit or Visit 1 (if Screening and Visit
1 are done on the same day);
17. (for selected healthy adult subjects agreeing to undergo PK blood draws) have
excessive consumption of caffeine- or xanthine-containing beverages (more than 4 cups
or servings per day) within 48 hours prior to dosing at Visit 1 or for the duration of
the study (see Appendix 3);
18. (for selected healthy adult subjects agreeing to undergo PK blood draws) have a
history of tobacco, nicotine, or nicotine-containing product use within 12 months
prior to Visit 1;
19. (for selected healthy adult subjects agreeing to undergo PK blood draws) have a
history or current evidence of drug or alcohol abuse within 12 months prior to Visit
1;
20. (for selected healthy adult subjects agreeing to undergo PK blood draws) have blood
donation or equivalent blood loss of >450 mL within 60 days prior to Visit 1.
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