A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
- Registration Number
- NCT03464435
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- vernal keratoconjunctivitis patients resistant to conventional treatments
- Patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description tacrolimus and loteprednol etabonate/tobramycin Tacrolimus topical eye drops
- Primary Outcome Measures
Name Time Method the change of objective ocular signs before treatment and 1, 2, 3 and 6 months after treatment doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
- Secondary Outcome Measures
Name Time Method the change of Best corrected visual acuity before treatment and 1, 2, 3 and 6 months after treatment doctors measure the change of BCVA
the change of intraocular pressure before treatment and 1, 2, 3 and 6 months after treatment doctors measure the change of BCVA
the change of subjective ocular symptoms before treatment and 1, 2, 3 and 6 months after treatment patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge