An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
NCT Number: NCT06538662
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Ocular Redness|Eye Irritation
Interventions: DRUG: FID 123320 Ophthalmic Solution|DRUG: Vehicle
Sponsor: Alcon Research
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-05

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.

Primary Outcome Measures: 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: 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