Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis.
Brief Summary: Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.


Options:
A: Inclusion Criteria:

* Must be at least one year of age.
* Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
* Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
* Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
* Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
* Must be willing to discontinue contact lens wear for the duration of the study.
* Must be willing to avoid disallowed medications during the study period.
* Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
* If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

* Any uncontrolled systemic disease or debilitating disease.
* Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
* Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
* Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
* Pregnant or nursing females.
* Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
* Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
* Ocular surgery (including laser surgery) in either eye within the past six weeks.
* Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
* Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
* History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
* Use of any antibiotic within 72 hours of enrollment.
* Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
* Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
* Subjects who were immune compromised.
B: Inclusion Criteria:

* Diagnosed with bacterial conjunctivitis in 1 or both eyes;
* Able to understand and sign an informed consent form. If subject is \<18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
* Agrees to comply with the visit schedule and other requirements of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
* Presence of concomitant viral infection;
* Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
* Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
* Infants undergoing treatment for retinopathy of prematurity;
* Contact lens wear during the course of the study;
* Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
* Use of medications, as specified in the protocol;
* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
* Known or suspected allergy or hypersensitivity to fluoroquinolones;
* Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
* Other protocol-specified exclusion criteria may apply.
C: Inclusion Criteria:

* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
* Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

* Pregnant or nursing females.
* Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
* Use of any antibiotic within 72 hours of treatment.
* Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
D: Inclusion Criteria:

* Male or female subject, of any race, who is at least 1 year of age.
* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
* The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
* Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

* Any uncontrolled, systemic, debilitating disease.
* Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
* Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
* Any active upper respiratory tract infection.
* Pregnant or nursing females.
* Use of any antibiotic (topical or systemic) within 72 hours of enrollment

Answer: C