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

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ClinicalTrials.gov Identifier: NCT00814515
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : July 16, 2010
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Moderate to Severe Dry Eye Syndrome Drug: NOVA22007 (Ciclosporin 0.1%) Drug: NOVA22007 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Ciclosporin 0.1%
Drug: NOVA22007 (Ciclosporin 0.1%)
Ciclosporin 0.1% Ophthalmic Emulsions
Placebo Comparator: 2
Vehicle
Drug: NOVA22007
Vehicle



Primary Outcome Measures :
  1. Corneal fluorescein staining (on modified Oxford scale) [ Time Frame: Approximately 26 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. • 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814515


Locations
France
Hôpital des XV-XX
Paris, Île-de-France, France, 75012
Sponsors and Collaborators
Santen SAS

Responsible Party: Mourad AMRANE, MD, Novagali Pharma
ClinicalTrials.gov Identifier: NCT00814515     History of Changes
Other Study ID Numbers: NVG06C103
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by Santen SAS:
Moderate
Severe
Dry
Eye
Ciclosporin
Cyclosporine

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