Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571656
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Evaluation of the Safety and Tolerability of Ocular Lubricants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety and Tolerability of Ocular Lubricants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease
Detailed Description:
Subjects will attend a total of 10 scheduled visits One Screening visit four Investigational Product visits four 12-hour Follow Up visits one for each Investigational Product visit and an Exit visit Subjects will receive one drop of the investigational product in each eye 2 drops total as randomized at each Investigational Product visit The first Investigational Product visit will occur 2 to 45 days after the Screening visit A washout period of 2 to 7 days will separate each Investigational Product visit Total duration of study participation for each subject will be approximately 25 months
This study will be conducted in Australia
This study will be conducted in Australia
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