Clinical Trial Results:
A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, 2 PARALLEL ARM, VEHICLE CONTROLLED, 6-MONTH PHASE III TRIAL WITH A 6 MONTH OPEN LABEL TREATMENT SAFETY FOLLOW-UP PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF CYCLOKAT® 1MG/ML (CICLOSPORIN/CYCLOSPORINE) EYE DROPS, EMULSION ADMINISTERED ONCE DAILY IN ADULT PATIENTS WITH SEVERE DRY EYE DISEASE (DED)
Summary
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EudraCT number |
2011-000160-97 |
Trial protocol |
SE BE DE IT AT GB CZ ES |
Global completion date |
13 Feb 2013
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Apr 2023
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First version publication date |
07 Apr 2023
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Other versions |
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Summary report(s) |
Synopsis CSR Sansika |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.