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

Sponsored by:	Novagali Pharma
Information provided by:	Novagali Pharma
ClinicalTrials.gov Identifier:	NCT00814515

Purpose

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

Condition	Intervention	Phase
Moderate to Severe Dry Eye Syndrome	Drug: NOVA22007 (Ciclosporin 0.1%) Drug: NOVA22007	Phase III

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novagali Pharma:

Primary Outcome Measures:

Corneal fluorescein staining (on modified Oxford scale) [ Time Frame: Approximately 26 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: Approximately 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	482
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ciclosporin 0.1%	Drug: NOVA22007 (Ciclosporin 0.1%) Ciclosporin 0.1% Ophthalmic Emulsions
2: Placebo Comparator Vehicle	Drug: NOVA22007 Vehicle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814515

Contacts

Contact: Mourad AMRANE, MD

+33 (0)1 69 87 40 20

mourad.amrane@novagali.com

Locations

France, Île-de-France
Hôpital des XV-XX	Recruiting
Paris, Île-de-France, France, 75012
Contact: Christophe Baudouin, Pr +33 (0)1 40 02 13 04

Sponsors and Collaborators

Novagali Pharma

More Information

Responsible Party:	Novagali Pharma ( Mourad AMRANE, MD )
Study ID Numbers:	NVG06C103
Study First Received:	December 24, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00814515
Health Authority:	France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Italy: Ethics Committee; Czech Republic: State Institute for Drug Control

Keywords provided by Novagali Pharma:

Moderate
Severe
Dry

Eye
Ciclosporin
Cyclosporine

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Eye Diseases

Tioconazole
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009