Vernal Keratoconjunctivitis
Conditions
Keywords
vernal keratoconjunctivitis, Tacrolimus eye drops
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
Interventions
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
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| time of persistence | during maintenance period of drug intake ( 2 months) | Reduction of exacerbations of inflammatory manifestations |
Contacts
Primary ContactEsraa Ahmed Okasha, assistant lecturer
Backup ContactEngy Mohamed Ahmed, professor
Outcome results
None listed