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.

Study Overview

• Status: Completed
• Conditions: Ocular Redness; Eye Irritation
• Intervention / Treatment: Drug: FID 123320 Ophthalmic Solution; Drug: Vehicle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • Canyon City Eyecare
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Butchertown Clinical Trials
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • North Carolina
    • Apex, North Carolina, United States, 27502
      • NC Eye Associates, OD, PLLC
    • Shelby, North Carolina, United States, 28150
      • Core, Inc.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care PA
    • Smyrna, Tennessee, United States, 37167
      • Advancing Vision Research, LLC
  • Texas
    • San Antonio, Texas, United States, 78249
      • Alamo Pediatric Eye Center, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FID 123320 Ophthalmic Solution - Adult Cohort; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: FID 123320 Ophthalmic Solution; Investigational sterile aqueous solution
Placebo Comparator: Vehicle - Adult Cohort; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: Vehicle; FID 123320 Ophthalmic Solution inactive ingredients
Experimental: FID 123320 Ophthalmic Solution - Pediatric Cohort; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: FID 123320 Ophthalmic Solution; Investigational sterile aqueous solution
Placebo Comparator: Vehicle - Pediatric Cohort; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: Vehicle; FID 123320 Ophthalmic Solution inactive ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale. This is a co-primary endpoint.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation
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)	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation
Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort	Ocular redness will be assessed by the investigator using a 0-4 unit ocular hyperemia scale.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort	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.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort	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.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort	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.	Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, Pharma, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Reduction of ocular redness
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Erythema; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: DEW422-C003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No