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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis
Compound Tacrolimus eye drops in 2 different concentrations will be assessed in treatment of vernal keratoconjunctivitis in terms of efficacy and safety being compared with steroid eye drops
Total subjective symptoms score (TSSS)
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)
Time frame: during loading period of drug intake ( 1 month )
Total objective ocular signs score (TOSS)
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)
Time frame: during loading period of drug intake ( 1 month )
visual acuity
management of acute episodes : with follow up of visual acuity using snellen chart
Time frame: during loading period of drug intake ( 1 month )
IOP measurement
management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
Time frame: during loading period of drug intake ( 1 month )
time of persistence
Reduction of exacerbations of inflammatory manifestations
Time frame: during maintenance period of drug intake ( 2 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.