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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05720715

Enrollment

Registered

2023-02-09

Start date

2022-01-01

Completion date

2024-03-01

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

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.

Interventions

DRUGcyclosporine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients diagnosed with herpetic stromal keratitis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
duration of ttt	3 months	duration of treatment until complete resolving of keratitis

Secondary

Measure	Time frame	Description
improvement in visual acuity	3 months	by snellen chart

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026