To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC patients who were not responding to conventional treatments. All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. After the first month, LE/T will be stopped, with other treatments continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The primary endpoints are the change in symptoms and objective signs. Treatment failure will be recorded if extra corticosteroids were required.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. 0.1% tacrolimus will be continued for the last 5 months.
the change of objective ocular signs
doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
Time frame: before treatment and 1, 2, 3 and 6 months after treatment
the change of Best corrected visual acuity
doctors measure the change of BCVA
Time frame: before treatment and 1, 2, 3 and 6 months after treatment
the change of intraocular pressure
doctors measure the change of BCVA
Time frame: before treatment and 1, 2, 3 and 6 months after treatment
the change of subjective ocular symptoms
patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge
Time frame: before treatment and 1, 2, 3 and 6 months after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.