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.

• FID 123320 Ophthalmic Solution (Drug): Investigational sterile aqueous solution
• Vehicle (Drug): FID 123320 Ophthalmic Solution inactive ingredients

Primary outcomes

• Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
• Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.
• Mean change from baseline in investigator-assessed ocular redness at 1 hour (60 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort (12-17 years) [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.

Secondary outcomes

• Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
• Mean change from baseline in the investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
• Mean change from baseline in the investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
• Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.
• Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.
• Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.
• Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort [Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation]: Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This endpoint is pre-specified for pediatric subjects in the age range of 12-17 years.

Sex: All, ages: 5 Years to any

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.

• Sr. Clinical Trial Lead, Pharma, Study director, Alcon Research, LLC