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OpenTrials
Completed

NCT Number: NCT01488396

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • has dry eye symptom everyday for more than 3 months
  • has foreign body sensation frequently
  • use tear substitutes more than 3 times per day
  • Tear test shaw abnormalities at least 1 of 2 of following:
  • Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
  • 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

Treatment and study plan

0.05%cyclosporin eye drop

Drug

use twice daily for 6 months

Other names: cyclosporin A

Primary outcomes

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

    Time frame: 0, 2, 4, 6 months

Secondary outcomes

  1. Schirmer I test

    Time frame: 0, 6 months

  2. Fluorescein clearance test (FCT)

    Time frame: 0, 6 month

  3. Corneal staining

    Time frame: 0, 2, 4, 6 months

    Staining with fluorescein and rose bengal

  4. Fluorescein tear break up time

    Time frame: 0, 2. 4. 6 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2011
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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