Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

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Brief Title

Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

Official Title

Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye

Brief Summary

      The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic
      emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by
      subjective symptoms and signs.
    

Detailed Description

      Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will
      be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months,
      compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein,
      Rose Bengal), Schirmer I,FCT and impression cytology
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

dry eyes symptoms : dryness, gritty, photophobia, burning and pain

Secondary Outcome

 Schirmer I test

Condition

Stevens-Johnson Syndrome

Intervention

0.05%cyclosporin eye drop

Study Arms / Comparison Groups

 0.05%cyclosporin eye drop
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

February 2007

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Males or females, of legal age of consent

          -  Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3
             months and has dry eye symptoms

          -  Dry eye symptoms are defined as

               1. has dry eye symptom everyday for more than 3 months

               2. has foreign body sensation frequently

               3. use tear substitutes more than 3 times per day

          -  Tear test shaw abnormalities at least 1 of 2 of following:

               1. Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes

               2. Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and
                  has at least 1 of 3 of the following:

        2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression
        cytology is consistent to dry eye

          -  Patent punctum

        Exclusion Criteria:

          -  Age < 18 years old

          -  Patients with Steven Johnson syndrome without dry eye

          -  Patients used oral cyclosporine or anticholinergic drug within past 2 months

          -  Patients with HIV or immunocompromise status

          -  Patients with active ocular infections and patients with a history of herpes keratitis

          -  Patients with known or suspected hypersensitivity to any of the ingredients in the
             formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)

          -  Female patients are pregnant or nursing
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pinnita Prabhasawat, MD, , 

Location Countries

Thailand

Location Countries

Thailand

Administrative Informations


NCT ID

NCT01488396

Organization ID

336/2549


Responsible Party

Principal Investigator

Study Sponsor

Mahidol University


Study Sponsor

Pinnita Prabhasawat, MD, Principal Investigator, Mahidol University


Verification Date

December 2011