Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

Sponsor

Farwaniya Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05720715

Collaborator

(none)

Enrollment

Location

Arms

13.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis	Drug: cyclosporine A 0.05% eye drops	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group A receive cyclosporine eye drops together with prednisolone eye drops.	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.
Placebo Comparator: group B receive topical prednisolone with placebo eye drops (tear replacement).	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.

Arm

Intervention/Treatment

Active Comparator: group A

receive cyclosporine eye drops together with prednisolone eye drops.

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.

Placebo Comparator: group B

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

Drug: cyclosporine A 0.05% eye drops

Outcome Measures

Primary Outcome Measures

duration of ttt [3 months]

Secondary Outcome Measures

improvement in visual acuity [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with herpetic stromal keratitis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Farwanyia Hospital	Al Farwānīyah	Farwanyia	Kuwait	13001

Sponsors and Collaborators

Farwaniya Hospital

Investigators

Study Chair: Salah Al-rasheedy, MD, Farwaniya Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nancy Lotfy, MD, Dr, Farwaniya Hospital

ClinicalTrials.gov Identifier:

NCT05720715

Other Study ID Numbers:

7080

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2023