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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | receive cyclosporine eye drops together with prednisolone eye drops. |
|
| group B | Placebo Comparator | receive topical prednisolone with placebo eye drops (tear replacement). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| duration of ttt | duration of treatment until complete resolving of keratitis | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| improvement in visual acuity | by snellen chart | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salah Al-rasheedy, MD | Farwaniya Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farwanyia Hospital | Al Farwaniyah | Farwanyia | 13001 | Kuwait |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41784713 | Derived | Lotfy NM, Alshatti H, Khachaba RY, Hagras SM. Evaluation of safety and efficacy of cyclosporine-A eye drops in herpetic stromal keratitis: a prospective randomized clinical trial. J Ophthalmic Inflamm Infect. 2026 Mar 5;16(1):14. doi: 10.1186/s12348-026-00573-2. |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |