Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029185
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-08
Brief Title:
Study of Dehydrex in Patients With Corneal Erosion
Sponsor:
Holles Laboratories Inc
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Topical Dehydrex in Treating Recurrent Corneal Erosion
Status:
COMPLETED
Status Verified Date:
2001-10
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:
This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex
Detailed Description:
This study continues to provide Dehydrex to patients who have received it previously under other studies Patients continue to be treated with their current dose of Dehydrex Upward dose adjustments may be made as clinically indicated Patients undergo eye exams every 3 to 4 months or more often Downward dose titration will be attempted in patients who are stable free of symptoms and willing to attempt downward adjustments In patients who are able to discontinue the medication duration of healing will be determined In those patients who experience a recurrence after discontinuing the medication Dehydrex will be restarted at a dose higher than the minimum effective dose After at least 8 weeks of treatment and resolution of symptoms the dose may again be reduced Further attempts to discontinue the medication will not be made
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| FD-R-001984-01 | None | None | None |