Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Phase 3
Completed
- Conditions
- Moderate to Severe Dry Eye Syndrome
- Interventions
- Drug: NOVA22007 (Ciclosporin 0.1%)
- Registration Number
- NCT00814515
- Lead Sponsor
- Santen SAS
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 482
Inclusion Criteria
- Males or females 18 years of age or greater.
- At baseline, moderate to severe dry eye condition persisting despite conventional management.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 NOVA22007 Vehicle 1 NOVA22007 (Ciclosporin 0.1%) Ciclosporin 0.1%
- Primary Outcome Measures
Name Time Method Corneal fluorescein staining (on modified Oxford scale) Approximately 26 weeks Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100% Approximately 26 weeks
- Secondary Outcome Measures
Name Time Method • Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to Approximately 26 weeks
Trial Locations
- Locations (1)
Hôpital des XV-XX
🇫🇷Paris, Île-de-France, France