Back to resultsDouble-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Primary Purpose
Moderate to Severe Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
NOVA22007 (Ciclosporin 0.1%)
NOVA22007
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Dry Eye Syndrome focused on measuring Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine
Eligibility Criteria
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.
Sites / Locations
- Hôpital des XV-XX
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Ciclosporin 0.1%
Vehicle
Outcomes
Primary Outcome Measures
Corneal fluorescein staining (on modified Oxford scale)
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%
Secondary Outcome Measures
• 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00814515
Brief Title
Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santen SAS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Dry Eye Syndrome
Keywords
Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
482 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Ciclosporin 0.1%
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
NOVA22007 (Ciclosporin 0.1%)
Intervention Description
Ciclosporin 0.1% Ophthalmic Emulsions
Intervention Type
Drug
Intervention Name(s)
NOVA22007
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Corneal fluorescein staining (on modified Oxford scale)
Time Frame
Approximately 26 weeks
Title
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%
Time Frame
Approximately 26 weeks
Secondary Outcome Measure Information:
Title
• 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
Time Frame
Approximately 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hôpital des XV-XX
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
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