Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis

Sohag University

Status: Not yet enrolling

Conditions: Vernal Keratoconjunctivitis

Treatments: Drug: Tacrolimus eye drops; Drug: Steroid eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT07138742

Soh-Med-25-7-5MD

Details and patient eligibility

About

The purpose of the study is to evaluate efficacy and safety of topical Tacrolimus eye drops in different concentrations in treatment of vernal keratoconjunctivitis (VKC) comparing it with Steroid based usual topical regimen

Full description

A hospital- based Prospective comparative randomized open label controlled trial . the study will be conducted on Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group). they will be divided into 2 groups control group will be treated with usual regimen ( steroid based) interventional group will be subdivided into 2 groups and each will be treated with Tacrolimus eye drops in 2 different concentrations

Follow up visits:

Will be scheduled 1st week , 2nd week then 4th week during the loading period Then every 2 weeks during the maintenance period Then monthly for another 3 months

Enrollment: 90 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)

Exclusion criteria

1. Coexisting eye infections
2. Contact lens use
3. Systemic immunosuppressive drug use
4. Herpes keratitis
5. Recent ocular surgery or trauma
6. Known hypersensitivity to Tacrolimus
7. Ophthalmological comorbidities as cataract, glaucoma, and congenital eye anomalies
8. Impaired renal or hepatic functions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control group

Active Comparator group

Description:

This group will be treated by steroid eye drops

Treatment:

Drug: Steroid eye drops

Intervention group 1

Experimental group

Description:

This group will be treated by compound Tacrolimus eye drop in 0.1% concentration

Treatment:

Drug: Tacrolimus eye drops

Intervention group 2

Experimental group

Description:

This group will be treated by compound Tacrolimus eye drop in 0.01% concentration

Treatment:

Drug: Tacrolimus eye drops