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; 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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-15
• Last Update Posted: 2010-07-16

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