NCT05720715

Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

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: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Farwaniya Hospital · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Interventions

Type	Name	Description
DRUG	cyclosporine A 0.05% eye drops	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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-02-09
• Last updated: 2024-08-07

Locations

1 site across 1 country: Kuwait