Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

NCT05720715 | Completed Phase 4

• 1 other identifier: 7080
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

Outcome Measures

Primary Outcomes (1)

• duration of ttt

  duration of treatment until complete resolving of keratitis

  3 months

Secondary Outcomes (1)

• improvement in visual acuity

  3 months

Study Arms (2)

group A

ACTIVE COMPARATOR

receive cyclosporine eye drops together with prednisolone eye drops.

Drug: cyclosporine A 0.05% eye drops

group B

PLACEBO COMPARATOR

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

Drug: cyclosporine A 0.05% eye drops

Interventions

cyclosporine A 0.05% eye drops 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 A; group B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with herpetic stromal keratitis

You may not qualify if:

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

Sponsors & Collaborators

• Farwaniya Hospital: lead

Study Sites (1)

Farwanyia Hospital

Al Farwānīyah, Farwanyia, 13001, Kuwait

Location

MeSH Terms

Interventions

Cyclosporine; Ophthalmic Solutions

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Salah Al-rasheedy, MD

  Farwaniya Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: January 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

KU (1)