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

This study has been completed.
Sponsor:
Information provided by:
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT00814515
First received: December 24, 2008
Last updated: July 15, 2010
Last verified: July 2010
  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 3

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
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

Resource links provided by NLM:


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
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ciclosporin 0.1%
Drug: NOVA22007 (Ciclosporin 0.1%)
Ciclosporin 0.1% Ophthalmic Emulsions
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hôpital des XV-XX
Paris, Île-de-France, France, 75012
Sponsors and Collaborators
Novagali Pharma
  More Information

No publications provided

Responsible Party: Mourad AMRANE, MD, Novagali Pharma
ClinicalTrials.gov Identifier: NCT00814515     History of Changes
Other Study ID Numbers: NVG06C103
Study First Received: December 24, 2008
Last Updated: July 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes
Cyclosporine
Cyclosporins
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014