An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
- Conditions
- Ocular RednessEye Irritation
- Interventions
- Drug: FID 123320 Ophthalmic SolutionDrug: Vehicle
- Registration Number
- NCT06538662
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FID 123320 Ophthalmic Solution FID 123320 Ophthalmic Solution 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). Vehicle Vehicle 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).
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method 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 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 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.
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.
Trial Locations
- Locations (10)
Canyon City Eyecare
🇺🇸Azusa, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
NC Eye Associates, OD, PLLC
🇺🇸Apex, North Carolina, United States
Advancing Vision Research, LLC
🇺🇸Smyrna, Tennessee, United States
Vision Institute
🇺🇸Colorado Springs, Colorado, United States
Butchertown Clinical Trials
🇺🇸Louisville, Kentucky, United States
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
CORE, Inc.
🇺🇸Shelby, North Carolina, United States
Total Eye Care PA
🇺🇸Memphis, Tennessee, United States
Alamo Pediatric Eye Center, PLLC
🇺🇸San Antonio, Texas, United States