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

This study will enroll 2 cohorts: An adult cohort (Subjects 18 years and older of age from any race and ethnicity) and a pediatric cohort (Subjects 5 - 17 years of age from any race and ethnicity).

The study will consist of 6 scheduled visits for each cohort: Screening and/or Baseline visit (Day -7 to -1, Visit 1), Eligibility verification/Randomization/1st Treatment visit on Day 1 (Visit 2), 2-week follow-up visit on Day 14 (Visit 3), 4-week follow-up visit on Day 28 (Visit 4), 8-week follow-up/Treatment discontinuation visit on Day 56 (Visit 5), and 7-day follow-up after treatment discontinuation/Exit visit on Day 63 (Visit 6). The primary endpoint will be collected at Day 1 (Visit 2).

The expected study duration for each subject is approximately 10 weeks with approximately 8 weeks (56 days) of investigational product (IP) exposure.

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.