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

2014-08-27 03:15:55 | BioPortfolio

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.

Study Design

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

Conditions

Keratoconjunctivitis, Vernal

Intervention

tacrolimus, cyclosporins

Location

Faculty of Medicine Siriraj Hospital
Bangkok
Thailand
10700

Status

Completed

Source

Siriraj Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:55-0400

Clinical Trials [331 Associated Clinical Trials listed on BioPortfolio]

Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

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Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

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Topical tacrolimus for the treatment of severe allergic keratoconjunctivitis in children.

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To evaluate the efficacy of topical tacrolimus 0.03% as steroid-free maintenance therapy in young patients with severe, recurrent phlyctenular keratoconjunctivitis (PKC).

Re: Topical Tacrolimus for Corneal Subepithelial Infiltrates Secondary to Adenoviral Keratoconjunctivitis.

Continuous Hydrologic and Water Quality Monitoring of Vernal Ponds.

Vernal ponds, also referred to as vernal pools, provide critical ecosystem services and habitat for a variety of threatened and endangered species. However, they are vulnerable parts of the landscapes...

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Tacrolimus is currently the cornerstone of immunosuppressive protocols for renal transplant recipients. Despite therapeutic whole blood monitoring, tacrolimus is associated with nephrotoxicity and it ...

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.

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