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Status unknownNCT03557203Updated Jun 14, 2018

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

An observational study in Vernal Keratoconjunctivitis, Atopic Keratoconjunctivitis and Tacrolimus, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 7 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-06-14.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
10
Ages
7 Years to 19 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Vernal Keratoconjunctivitis
  • Atopic Keratoconjunctivitis
  • Tacrolimus

Keywords

  • Vernal Keratoconjunctivitis
  • Atopic Keratoconjunctivitis
  • tacrolimus
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In context

Keratoconjunctivitis

117 studies on the registry are indexed under Keratoconjunctivitis; 4 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 21 observational studies indexed under Keratoconjunctivitis.

Browse Keratoconjunctivitis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 19 Years
Sexes eligible
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)

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

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
10 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

    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.

    Time frame: 2018/6/1-2019/5/31

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03557203
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jun 14, 2018
Start date
Jun 1, 2018
Primary completion
May 31, 2019 (estimated)
Completion
May 31, 2019 (estimated)
Last update
Jun 14, 2018

Study contacts

I-Jong Wang, professor
Contact
ijong@ntu.edu.tw
886-2-23123456 ext. 65729
I-Jong Wang, professor
principal investigator · National Taiwan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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