Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
- Conditions
- Vernal Keratoconjunctivitis
- Interventions
- Drug: Steroid eye drops
- Registration Number
- NCT07138742
- Lead Sponsor
- Sohag University
- Brief Summary
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
- Detailed 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)
- Coexisting eye infections
- Contact lens use
- Systemic immunosuppressive drug use
- Herpes keratitis
- Recent ocular surgery or trauma
- Known hypersensitivity to Tacrolimus
- Ophthalmological comorbidities as cataract, glaucoma, and congenital eye anomalies
- Impaired renal or hepatic functions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Steroid eye drops This group will be treated by steroid eye drops Intervention group 2 Tacrolimus eye drops This group will be treated by compound Tacrolimus eye drop in 0.01% concentration Intervention group 1 Tacrolimus eye drops This group will be treated by compound Tacrolimus eye drop in 0.1% concentration
- Primary Outcome Measures
Name Time Method Total subjective symptoms score (TSSS) during loading period of drug intake ( 1 month ) management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total subjective symptoms score (TSSS)
Total objective ocular signs score (TOSS) during loading period of drug intake ( 1 month ) management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total objective ocular signs score (TOSS)
visual acuity during loading period of drug intake ( 1 month ) management of acute episodes : with follow up of visual acuity using snellen chart
IOP measurement during loading period of drug intake ( 1 month ) management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
- Secondary Outcome Measures
Name Time Method time of persistence during maintenance period of drug intake ( 2 months) Reduction of exacerbations of inflammatory manifestations