Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557203
Recruitment Status : Unknown
Verified May 2018 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis and atopic keratoconjunctivitis.

Condition or disease
Vernal Keratoconjunctivitis Atopic Keratoconjunctivitis Tacrolimus

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : June 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 [ 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557203


Contacts
Layout table for location contacts
Contact: I-Jong Wang, professor 886-2-23123456 ext 65729 ijong@ntu.edu.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: I-Jong Wang    886-2-23123456 ext 65729    ijong@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: I-Jong Wang, professor National Taiwan University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03557203    
Other Study ID Numbers: 201804062RIND
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: May 2018

Layout table for additional information
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:
Vernal Keratoconjunctivitis
Atopic Keratoconjunctivitis
tacrolimus
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases