An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations

Key Inclusion Criteria - Adult Cohort:

• Capable of giving signed informed consent;

• Willing and able to follow all instructions and attend all study visits;

• Able to self-administer eye drops in the opinion of the investigator;

• Have a history of vasoconstrictor (redness relief drop) use within the last 6 months, have an interest in using over-the-counter (OTC) vasoconstrictor eye drops for redness relief, or would benefit from the use of redness relief drops in the opinion of the investigator;

• Ocular health within normal limits, including distance best corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;

• Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;

• Other protocol-defined inclusion criteria may apply.

Key Inclusion Criteria - Pediatric Cohort:

• All pediatric subjects: Parent or legal guardian signs informed consent;

• Pediatric subject ages 7-17: Sign an assent form;

• Subject and parent/legal guardian/care giver: Willing and able to follow all instructions and attend all study visits;

• Able to self-administer eye drops satisfactorily or have a subject's care provider or parent/legal guardian at home routinely available for this purpose;

• Ocular health within normal limits; best-corrected visual acuity of 20/40 or better in each eye as measured using a Snellen chart;

• Stable ocular health (defined as no ocular conditions requiring therapy or surgical intervention) during the study;

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria - Pediatric and Adult Cohorts

• Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;

• Ocular surgical intervention within 6 months prior to Visit 1 (Day -7 to Day -1) or during the study;

• History of lid surgery;

• Ocular condition that, in the opinion of the investigator, could affect the subject's safety or study parameters;

• Other protocol-specified exclusion criteria may apply.