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A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT03464435
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Vernal Keratoconjunctivitis Drug: Tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : February 1, 2018


Arm Intervention/treatment
Experimental: tacrolimus and loteprednol etabonate/tobramycin
topical eye drops
Drug: Tacrolimus
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.
Other Name: loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)




Primary Outcome Measures :
  1. the change of objective ocular signs [ Time Frame: 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 :
  1. the change of Best corrected visual acuity [ Time Frame: before treatment and 1, 2, 3 and 6 months after treatment ]
    doctors measure the change of BCVA

  2. the change of intraocular pressure [ Time Frame: before treatment and 1, 2, 3 and 6 months after treatment ]
    doctors measure the change of BCVA

  3. the change of subjective ocular symptoms [ Time Frame: before treatment and 1, 2, 3 and 6 months after treatment ]
    patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Jin Yuan, professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03464435     History of Changes
Other Study ID Numbers: ZOC2017001123
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University:
Refractory Vernal Keratoconjunctivitis
0.1% tacrolimus
loteprednol etabonate 0.5%/tobramycin 0.3%
Additional relevant MeSH terms:
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Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loteprednol Etabonate
Tobramycin
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents