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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01068054
Other study ID # fk506vscyclosporine_vkc
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 11, 2010
Last updated February 11, 2010
Start date June 2003
Est. completion date May 2005

Study information

Verified date June 2003
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.


Description:

Background: Vernal keratoconjunctivitis (VKC) is a serious, sight-threatening ocular disease, occurring mainly in children. Prolonged use of ophthalmic corticosteroids is usually required in severe cases which could lead to serious complications such as glaucoma and cataract. Cyclosporine and tacrolimus are among newer treatments for VKC.

Objective: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of VKC.

Methods: Twenty-four patients with VKC were recruited. After a 2 week-washout period, they were randomized into 2 groups in a double-blinded, parallel fashion. The first group received 0.1% FK-506 eye ointment with placebo eye drops and the second group received 2% cyclosporine eye drops with placebo ointment for 8 weeks. Thereafter, all patients received an open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms and side effects were scored by patients at the entry, and at the end of the 1st, 4th, 8th and 12th weeks. Objective ocular signs were evaluated by an ophthalmologist (PK) at all follow up visits.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with clinical diagnosis of vernal keratoconjunctivitis

Exclusion Criteria:

- coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections, other coexisting systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
tacrolimus
0.1% ointment,apply bid, 8 weeks
cyclosporins
2% eyclosporine eye drops apply 1 drop to each eye QID

Locations

Country Name City State
Thailand Faculty of Medicine Siriraj Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall subjective ocular symptom scores 8 weeks No
Secondary overall objective ocular signs 8 weeks No
Secondary overall side-effect scores 8 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT00357019 - Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis Phase 4