Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
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.
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.
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Faculty of Medicine Siriraj Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01068054
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.
A group of closely related cyclic undecapeptides from the fungi Trichoderma polysporum and Cylindocarpon lucidum. They have some antineoplastic and antifungal action and significant immunosuppressive effects. Cyclosporins have been proposed as adjuvants in tissue and organ transplantation to suppress graft rejection.
A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.
A species of gram-negative, aerobic bacteria that is most frequently isolated from bovine eyes in cases of infectious keratoconjunctivitis (KERATOCONJUNCTIVITIS, INFECTIOUS), but also occurs in unaffected eyes and the nasal cavity of cattle.
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
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