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

NCT06538662 | Completed Phase 3 FDA Drug

• 1 other identifier: DEW422-C003
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Ocular Redness; Eye Irritation

Keywords

Reduction of ocular redness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

FID 123320 Ophthalmic Solution - Adult Cohort

EXPERIMENTAL

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

Vehicle - Adult Cohort

PLACEBO COMPARATOR

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 - Pediatric Cohort

EXPERIMENTAL

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

Vehicle - Pediatric Cohort

PLACEBO COMPARATOR

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

Interventions

Vehicle DRUG

FID 123320 Ophthalmic Solution inactive ingredients

Vehicle - Adult Cohort; Vehicle - Pediatric Cohort

FID 123320 Ophthalmic Solution DRUG

Investigational sterile aqueous solution

FID 123320 Ophthalmic Solution - Adult Cohort; FID 123320 Ophthalmic Solution - Pediatric Cohort

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (10)

Canyon City Eyecare

Azusa, California, 91702, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

NC Eye Associates, OD, PLLC

Apex, North Carolina, 27502, United States

Location

CORE, Inc.

Shelby, North Carolina, 28150, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research, LLC

Smyrna, Tennessee, 37167, United States

Location

Alamo Pediatric Eye Center, PLLC

San Antonio, Texas, 78249, United States

Location

Study Officials

• Sr. Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: October 7, 2024
• Primary Completion: January 27, 2025
• Study Completion: April 3, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)