Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

Farwaniya Hospital

Status and phase: Completed; Phase 4

Conditions: Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Treatments: Drug: cyclosporine A 0.05% eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT05720715

7080 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with herpetic stromal keratitis

Exclusion criteria

• associated ocular diseases, DM, renal disease, pregnancy, breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

group A

Active Comparator group

Description:

receive cyclosporine eye drops together with prednisolone eye drops.

Treatment:

Drug: cyclosporine A 0.05% eye drops

group B

Placebo Comparator group

Description:

receive topical prednisolone with placebo eye drops (tear replacement).

Treatment:

Drug: cyclosporine A 0.05% eye drops