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

Moderate to Severe Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814515
• Other study ID #: NVG06C103
• Status: Completed
• Phase: Phase 3
• First received: December 24, 2008
• Last updated: July 15, 2010
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2010
• Source: Novagali Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesItaly: Ethics CommitteeCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Moderate to Severe Dry Eye Syndrome
• Syndrome

Intervention

Drug:
• NOVA22007 (Ciclosporin 0.1%)
Ciclosporin 0.1% Ophthalmic Emulsions
• NOVA22007
Vehicle

Locations

Country	Name	City	State
France	Hôpital des XV-XX	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Novagali Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal fluorescein staining (on modified Oxford scale)		Approximately 26 weeks	Yes
Primary	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	Yes
Secondary	• 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	Yes