Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01068054|
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : February 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Keratoconjunctivitis, Vernal||Drug: tacrolimus Drug: cyclosporins||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)|
|Study Start Date :||June 2003|
|Primary Completion Date :||May 2005|
|Study Completion Date :||May 2005|
Active Comparator: tacrolimus
Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID
0.1% ointment,apply bid, 8 weeks
Active Comparator: cyclosporine
2% cyclosporine eye drops apply QID + placebo eye ointment apply bid
2% eyclosporine eye drops apply 1 drop to each eye QID
- overall subjective ocular symptom scores [ Time Frame: 8 weeks ]
- overall objective ocular signs [ Time Frame: 8 weeks ]
- overall side-effect scores [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068054
|Faculty of Medicine Siriraj Hospital|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Pakit Vichyanond, MD||Faculty of Medicine Siriraj Hospital|