A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Status:
Completed
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University