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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus and loteprednol etabonate/tobramycin | Experimental | topical eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the change of objective ocular signs | doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining | before treatment and 1, 2, 3 and 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| the change of Best corrected visual acuity | doctors measure the change of BCVA | before treatment and 1, 2, 3 and 6 months after treatment |
| the change of intraocular pressure | doctors measure the change of BCVA |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000730 | Androstadienes |
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|
| 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 | before treatment and 1, 2, 3 and 6 months after treatment |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D000736 |
| Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |