Back to resultsClinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
Primary Purpose
Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
Status
Recruiting
Phase
Phase 4
Locations
Kuwait
Study Type
Interventional
Intervention
cyclosporine A 0.05% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with herpetic stromal keratitis Exclusion Criteria: associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
Sites / Locations
- Farwanyia HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
group A
group B
Arm Description
receive cyclosporine eye drops together with prednisolone eye drops.
receive topical prednisolone with placebo eye drops (tear replacement).
Outcomes
Primary Outcome Measures
duration of ttt
duration of treatment until complete resolving of keratitis
Secondary Outcome Measures
improvement in visual acuity
by snellen chart
Full Information
NCT ID
NCT05720715
First Posted
January 31, 2023
Last Updated
September 11, 2023
Sponsor
Farwaniya Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05720715
Brief Title
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Farwaniya Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
receive cyclosporine eye drops together with prednisolone eye drops.
Arm Title
group B
Arm Type
Placebo Comparator
Arm Description
receive topical prednisolone with placebo eye drops (tear replacement).
Intervention Type
Drug
Intervention Name(s)
cyclosporine A 0.05% eye drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
duration of ttt
Description
duration of treatment until complete resolving of keratitis
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement in visual acuity
Description
by snellen chart
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with herpetic stromal keratitis
Exclusion Criteria:
associated ocular diseases, DM, renal disease, pregnancy, breast feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Lotfy, MD
Phone
01006030381
Email
nancymaher@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Al-rasheedy, MD
Organizational Affiliation
Farwaniya Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Farwanyia Hospital
City
Al Farwānīyah
State/Province
Farwanyia
ZIP/Postal Code
13001
Country
Kuwait
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salah Alrashidi, MD
Phone
99446100
Ext
00965
Email
salahr@doctor.com
First Name & Middle Initial & Last Name & Degree
Nancy m Lotfy, MD
Phone
01006030381
Ext
00965
Email
nancymaher@kasralainy.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
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