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Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

NCT05720715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Farwaniya Hospital

    lead OTHER_GOV

Principal Investigators

  • Salah Al-rasheedy, MD · Farwaniya Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-03-01
Completion
2024-03-01

Countries

  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720715 on ClinicalTrials.gov