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

June 4, 2018 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: I-Jong Wang, professor
  • Phone Number: 65729 886-2-23123456
  • Email: ijong@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
2018/6/1-2019/5/31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201804062RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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