Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03557203
Collaborator
(none)
10
1
12
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Study Details

Study Description

Brief Summary

To evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis and atopic keratoconjunctivitis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Treatment of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) is a challenge for the ophthalmologist and patients because of its wide variation in presentation and recurrence in nature. Patients has to be dependent on long term steroid control and suffered from complications, such as steroid glaucoma and secondary infection. About 32% of VKC patients is refractory to steroid treatment and another 35.4% of patients showed partial response. Tacrolimus ointment or eye drops are promising anti-inflammatory agents that have been shown very effective against VKC for patients suffering from severe VKC resistant to topical cyclosporine. Although tacrolimus eye drops is very effective in severe cases of VKC, unfortunately, it is only available in limited countries. Because of the unavailability of tacrolimus eye drops and side effect of long-tern steroid use, we tried to find other options for these severe VKC and AKC. Because there will be concomitant atopic dermatitis in the eyelid of severe cases of VKC and AKC, we retrospectively collected in cases using topical tacrolimus dermatological ointment on the skin of upper eye lid in the treatment of severe VKC and AKC with concomitant atopic dermatitis. Here, we reported 10 cases with either VKC or AKC whose symptoms resolved significantly with dermatologic tacrolimus ointment applying on eyelids.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Steroid Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
    Actual Study Start Date :
    Jun 1, 2018
    Anticipated Primary Completion Date :
    May 31, 2019
    Anticipated Study Completion Date :
    May 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. serial external ocular photography and full chart records of patients who diagnosed as patients diagnosed as severe vernal keratoconjunctivitis and atopic keratoconjunctivitis refractory to steroid treatment [2018/6/1-2019/5/31]

      A retrospective review of charts and external ocular photography of all patients diagnosed as severe VKC or AKC and received topical dermatological tacrolimus ointment on upper eyelids between January, 2016 and January, 2018 at National Taiwan University Hospital.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all patients diagnosed as severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis and received topical dermatological tacrolimus ointment on upper eyelids between January, 2016 and January, 2018 at National Taiwan University Hospital.
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: I-Jong Wang, professor, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03557203
    Other Study ID Numbers:
    • 201804062RIND
    First Posted:
    Jun 14, 2018
    Last Update Posted:
    Jun 14, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 14, 2018