Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538662
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor Baseline visit Day -7 to -1 Visit 1 Eligibility verificationRandomization1st 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-upTreatment discontinuation visit on Day 56 Visit 5 and 7-day follow-up after treatment discontinuationExit 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
The study will consist of 6 scheduled visits for each cohort Screening andor Baseline visit Day -7 to -1 Visit 1 Eligibility verificationRandomization1st 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-upTreatment discontinuation visit on Day 56 Visit 5 and 7-day follow-up after treatment discontinuationExit 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None