Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-23 @ 9:31 PM
Study NCT ID:
NCT05720715
Status:
None
Last Update Posted:
2024-08-07 00:00:00
First Post:
2023-01-31 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Cyclosporine A 0.05% Eye Drops in Management of Non- Necrotizing Herpetic Stromal Keratitis; a Prospective Controlled Clinical Trial
Status:
None
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:
Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.
Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.
Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.
Group B: receive topical prednisolone with placebo eye drops (tear replacement).
The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.
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?: