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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
283
Investigational sterile aqueous solution
FID 123320 Ophthalmic Solution inactive ingredients
Canyon City Eyecare
Azusa, California, United States
Eye Research Foundation
Newport Beach, California, United States
Vision Institute
Colorado Springs, Colorado, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 1 hour (60 minutes) post-instillation
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.
Time frame: 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.
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 8 hours (480 minutes) post-instillation
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Butchertown Clinical Trials
Louisville, Kentucky, United States
Andover Eye Associates
Andover, Massachusetts, United States
NC Eye Associates, OD, PLLC
Apex, North Carolina, United States
CORE, Inc.
Shelby, North Carolina, United States
Total Eye Care PA
Memphis, Tennessee, United States
Advancing Vision Research, LLC
Smyrna, Tennessee, United States
Alamo Pediatric Eye Center, PLLC
San Antonio, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (Visit 2) pre-instillation; Day 1 (Visit 2) at 30 seconds post-instillation