Eye Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Patients of consenting parents, who have also given assent to the study • Patients aged 4-18 years with clinical diagnosis of moderate to severe Vernal Keratoconjunctivitis at screening • Patient with refractive error with spherical equivalent <+/- 5.00DS • Patients of parents that are willing and able to comply with prescribed treatment protocol and evaluations for the duration of the study • Patients that do not require surgical ophthalmological intervention
Exclusion criteria
Exclusion criteria: • Patients with background ocular surface disease such as blepharitis, mebomian gland dysfunction, Steven Johnson Syndrome other than VKC • Patients blind in one eye, • Patients with coexisting co existing, asthma, atopic dermatitis on systemic therapy • Children who have had extraocular and intraocular ophthalmic surgical intervention • Patients with history of contact lens usage, • Patients with glaucoma or ocular hypertension or treated with steroids in the last 3 months • Patients with coexisting ocular infections, • Patients with past history or known hypersensitivity to tacrolimus. • Patients with shield ulcers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study’s primary outcome is the change in total composite score from baseline for VKC-related symptoms and signs at 4 and 8 weeks post treatment with study medications | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in tolerability score at baseline,4 weeks and after 8 weeks post treatment with study medications;Difference in IOP after 4 weeks and 8 weeks post treatment with study medications from baseline IOP value | — |
Countries
Nigeria
Contacts
Senior registrar