Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444529
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-31
Brief Title:
A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 Apraclonidine Hydrochloride Ophthalmic Solution 0125 when compared to Vehicle in relieving redness of the eye due to minor eye irritations This study will be conducted in the United States
Detailed Description:
The study will consist of six 6 scheduled visits Screening andor Baseline Visit Day -7 to -1 Eligibility ConfirmationRandomization1st Treatment Visit Day 1 Week 2 Follow-Up Visit Day 14 Week 4 Follow-Up Visit Day 28 Week 8 Follow-UpTreatment Discontinuation Visit Day 56 and Exit Visit Day 63 The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None