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

A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Efficacy and Safety Study of FID 123320 Ophthalmic Solution for the Reduction of Ocular Redness in Pediatric and Adult Populations

The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution compared to Vehicle for relieving redness of the eye due to minor eye irritations 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.