Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

Keratoconjunctivitis, Vernal Clinical Trial

Official title:

A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068054
• Other study ID #: fk506vscyclosporine_vkc
• 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

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Keratoconjunctivitis, Vernal

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