Status:
COMPLETED
Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Lead Sponsor:
Santen SAS
Conditions:
Moderate to Severe Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
Eligibility Criteria
Inclusion
- Males or females 18 years of age or greater.
- At baseline, moderate to severe dry eye condition persisting despite conventional management.
Exclusion
- Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
- Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
- Any other ocular diseases requiring topical ocular treatment during the study period.
- Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
- Participation in another clinical study at the same time as the present study.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT00814515
Start Date
September 1 2007
End Date
September 1 2009
Last Update
July 16 2010
Active Locations (1)
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1
Hôpital des XV-XX
Paris, Île-de-France Region, France, 75012