Understanding the role of Cyclosporin A drops in control of ocular inflammation in acute cases of Stevens Johnson Syndrome
| ISRCTN | ISRCTN11036223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11036223 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/05/2016
- Registration date
- 03/10/2016
- Last edited
- 03/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims (to set the scene)
Stevens Johnson Syndrome (SJS) is a serious, but rare, disorder of the skin and mucous membranes. It is usually caused by taking a particular medicine or in response to a infection. Patients usually first experience flu-like symptoms, followed by skin pain, facia and tongue swelling, a skin rash, blisters on the skin and mucous membranes of the nose, eyes and genitals and shedding of the skin. Acute ocular inflammation (inflammation of the middle layer of the eye) in SJS is present between 43%-81% of patients and up to 35% of them may experience permanent damamge to their sight. In order to prevent as much damage to a patients sight as possible, prevention of ocular complications (complications connected to the eyes or vision) is vital. Systemic steroids have been used in the past but these can cause significant side effects and can result in secondary infections. The aim of this study is to test how effective cyclosporine (a drug that supresses the immune system) is at controlling acute ocular inflammation in patients with SJS.
Who can participate?
Patients suffering from acute SJS.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are treated with cyclosporine eye drops as well as standard treatment for SJS; this includes topical antibiotics (eye drops), frequent lubrication of the eyes in the form of artificial tears and eye ointment. The eyes are also washed daily with saline.Patients in group 2 are treated only with topical antibiotics, frequent lubrication of the eyes in the form of artificial tears and eye ointment. All patients are then followed up for a period of one year to assess the effects of the treatment.
What are the possible benefits and risks of participating?
Participation in the study is voluntary and no risk is associated with it. Patients can refuse to participate or withdraw at any time without it affecting their treatment. All information obtained for this study is used for research purposes only and will be kept strictly confidential.
Where is the study run from?
Dr. R.P. Centre for Ophthalmic Sciences, New Delhi (India)
When is the study starting and how long is it expected to run for?
December 2007 to November 2010
Who is funding the study?
Indian Council of Medical Research
Who is the main contact?
Professor Namrata Sharma
Contact information
Scientific
Room No.481, Fourth Floor
Dr.Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute for Medical Sciences
Ansari Nagar
New Delhi
110029
India
Study information
| Study design | A double blind randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of topical Cyclosporin A drops in control of ocular inflammation in acute Stevens Johnson Syndrome |
| Study objectives | The aim of this study is evaluate the use of topical cyclosporine A drops in control of acute inflammation in acute Stevens Johnson Syndrome (SJS). This includes comparison of the following: 1. Assessment of ocular surface status 2. Improvement in tear film status 3. Corneal vascularization status |
| Ethics approval(s) | Institutional Ethics Committee , All India Institute of Medical Sciences, 04/03/2007 |
| Health condition(s) or problem(s) studied | Acute Stevens-Johnson Syndrome |
| Intervention | Participants are randomly allocated to one of two groups. Those in group 1 are treated with topical Cyclosporin A 1% drops along with the standard regime, followed from the day one of presentation. These patients are prescribed topical antibiotics, frequent lubrication in the form of artificial tears and lubricant eye ointment. Daily lysis of the symblepharon with copious irrigation with normal saline to wash of all the debris is also done. Participants in group 2 are treated only with topical antibiotics and frequent lubrication with artificial tears drops and lubricant eye ointment. |
| Intervention type | |
| Primary outcome measure | 1. Degree of inflammation, assessed using grading score for inflammation (conjunctival hyperaemia) 2. Degree of corneal vascularisation, assessed using grading score for corneal vascularisation Measured pre-treatment and post treatment. |
| Secondary outcome measures | 1. Any improvement in tear secretions, assessed using schirmer’s test 2. Ocular surface status, assessed using overall grading for ocular surface parameters Measured pre-treatment and post treatment. |
| Overall study start date | 01/12/2007 |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 30 patients in case group, 30 patients in control group |
| Key inclusion criteria | Patients of acute Stevens Johnson Syndrome |
| Key exclusion criteria | 1. Pregnant females 2. Lactating females 3. Children below 2 years 4. Patients who refuse consent 5. Patients with known sensitivity to cyclosporin 6. Patients with cardiac, renal and hepatic failure |
| Date of first enrolment | 02/12/2007 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- India
Study participating centre
Ansari Nagar
New Delhi
110029
India
Sponsor information
Government
Ansari Nagar
New Delhi
110029
India
| Website | http://www.aiims.edu/en.html |
|---|---|
"ROR" |
https://ror.org/02dwcqs71 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Results and Publications
| Intention to publish date | 30/11/2011 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
