Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00814515
• Date of registration: 24/12/2008
• Prospective Registration: No
• Primary sponsor: Novagali Pharma
• Public title: Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 482
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00814515
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Moderate to Severe Dry Eye Syndrome

Intervention(s)

Drug: NOVA22007

Drug: NOVA22007 (Ciclosporin 0.1%)

Primary Outcome(s)

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]

Corneal fluorescein staining (on modified Oxford scale) [Time Frame: Approximately 26 weeks]

Secondary Outcome(s)

• 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]

Secondary ID(s)

NVG06C103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors