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CompletedNCT05720715Updated Aug 7, 2024

Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

A Phase 4 interventional study of cyclosporine A 0.05% eye drops in Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis, sponsored by Farwaniya Hospital. Completed at 1 site in Kuwait. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Farwaniya Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2022, registered Jan 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

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.

02

Conditions studied

  • Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis

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03

In context

Keratitis

108 studies on the registry are indexed under Keratitis; 19 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 70 interventional studies indexed under Keratitis.

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Lead sponsor

Farwaniya Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with herpetic stromal keratitis

Exclusion criteria

Exclusion Criteria:

  • associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    group A

    receive cyclosporine eye drops together with prednisolone eye drops.

    Drug: cyclosporine A 0.05% eye drops

  • Placebo comparator
    group B

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

    Drug: cyclosporine A 0.05% eye drops

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. duration of ttt

    duration of treatment until complete resolving of keratitis

    Time frame: 3 months

Secondary outcomes

  1. improvement in visual acuity

    by snellen chart

    Time frame: 3 months

07

Study locations

1 site
  • Farwanyia Hospital
    Al Farwānīyah, Farwanyia 13001, Kuwait
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05720715
Lead sponsor
Farwaniya Hospital
Responsible party
Nancy Lotfy, MD (Dr, Farwaniya Hospital) — Principal investigator
First posted
Feb 9, 2023
Start date
Jan 1, 2022
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Last update
Aug 7, 2024

Study contacts

Salah Al-rasheedy, MD
study chair · Farwaniya Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cyclosporine

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