Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01684852
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2012-09-11
Brief Title:
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution
Sponsor:
Bitop AG
Organization:
Bitop AG
Study Overview
Official Title:
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution BAT04 Compared to HA Eye Drops in the Treatment of Dry Eye Disease
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This is a comparative open label parallel group non interventional study to further demonstrate the efficacy and tolerability of BAT04 In addition the efficacy and safety shall be compared to Hyaluronic acid HA-Product The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days Response to treatment is recorded at day 28
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIS BAT04 | None | None | None |