A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Primary Purpose
Vernal Keratoconjunctivitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Vernal Keratoconjunctivitis focused on measuring Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tacrolimus and loteprednol etabonate/tobramycin
Arm Description
topical eye drops
Outcomes
Primary Outcome Measures
the change of objective ocular signs
doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
Secondary Outcome Measures
the change of Best corrected visual acuity
doctors measure the change of BCVA
the change of intraocular pressure
doctors measure the change of BCVA
the change of subjective ocular symptoms
patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge
Full Information
NCT ID
NCT03464435
First Posted
March 7, 2018
Last Updated
March 7, 2018
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03464435
Brief Title
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Official Title
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vernal Keratoconjunctivitis
Keywords
Refractory Vernal Keratoconjunctivitis, 0.1% tacrolimus, loteprednol etabonate 0.5%/tobramycin 0.3%
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tacrolimus and loteprednol etabonate/tobramycin
Arm Type
Experimental
Arm Description
topical eye drops
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of objective ocular signs
Description
doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining
Time Frame
before treatment and 1, 2, 3 and 6 months after treatment
Secondary Outcome Measure Information:
Title
the change of Best corrected visual acuity
Description
doctors measure the change of BCVA
Time Frame
before treatment and 1, 2, 3 and 6 months after treatment
Title
the change of intraocular pressure
Description
doctors measure the change of BCVA
Time Frame
before treatment and 1, 2, 3 and 6 months after treatment
Title
the change of subjective ocular symptoms
Description
patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge
Time Frame
before treatment and 1, 2, 3 and 6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis
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