Vernal Keratoconjunctivitis
Conditions
Keywords
Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%
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.
Interventions
DRUGTacrolimus
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.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* vernal keratoconjunctivitis patients resistant to conventional treatments
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed