Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

NCT ID: NCT05720715

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group A

receive cyclosporine eye drops together with prednisolone eye drops.

Group Type ACTIVE_COMPARATOR

cyclosporine A 0.05% eye drops

Intervention Type DRUG

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.

group B

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

Group Type PLACEBO_COMPARATOR

cyclosporine A 0.05% eye drops

Intervention Type DRUG

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

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with herpetic stromal keratitis

Exclusion Criteria

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

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farwaniya Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nancy Lotfy, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salah Al-rasheedy, MD

Role: STUDY_CHAIR

Farwaniya Hospital

Locations

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Farwanyia Hospital

Al Farwānīyah, Farwanyia, Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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7080

Identifier Type: -

Identifier Source: org_study_id

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