Vernal KeratoconjunctivitisNCT03557203
Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
An observational study of Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis and atopic keratoconjunctivitis. Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Vernal Keratoconjunctivitis, Atopic Keratoconjunctivitis, Tacrolimus
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
I-Jong Wang, 886-2-23123456 ext. 65729, ijong@ntu.edu.tw
About this study
Official title: 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.
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.
- Keywords
- Vernal Keratoconjunctivitis, Atopic Keratoconjunctivitis, tacrolimus
- Medical subject headings
- Conjunctivitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018/6/1-2019/5/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jun 2018
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Jong Wang, professor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557203
- Sponsor's protocol ID
- 201804062RIND
- Status last verified
- May 2018
- First submitted
- 4 Jun 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Steroid Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT03557203
- Acronym / sponsor ID
- 201804062RIND
- Keywords
- Vernal Keratoconjunctivitis, Atopic Keratoconjunctivitis, tacrolimus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the therapeutic effects of dermatologic tacrolimus ointment on eyelids to treat refractory vernal keratoconjunctivitis and atopic keratoconjunctivitis.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Severe vernal keratoconjunctivitis or atopic Keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Jong Wang, professor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Jong Wang, professor (886-2-23123456 ext. 65729, ijong@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.