Clinical trial NCT06538662: An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Redness
Eye Irritation
Keywords: Reduction of ocular redness
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 283
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 15 minutes post-instillation
measure: Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 10 hours (600 minutes) post-instillation
measure: 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)
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation
Secondary outcomes:
measure: Mean change from baseline in the investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
measure: Mean change from baseline in the investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
measure: Mean change from baseline in the investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 12 hours (720 minutes) post-instillation
measure: Mean change from baseline in the investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Adult Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
measure: Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) - Pediatric Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 minute post-instillation
measure: Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 (Visit 2) - Pediatric Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
measure: Mean change from baseline in investigator assessed ocular redness at 30 seconds post-instillation on Day 1 (Visit 2) - Pediatric Cohort
timeFrame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Canyon City Eyecare
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Apex
country: United States
facility: NC Eye Associates, OD, PLLC
state: North Carolina
city: Shelby
country: United States
facility: CORE, Inc.
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care PA
state: Tennessee
city: Smyrna
country: United States
facility: Advancing Vision Research, LLC
state: Tennessee
city: San Antonio
country: United States
facility: Alamo Pediatric Eye Center, PLLC
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References: