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

This study has been completed.
Information provided by:
Santen SAS Identifier:
First received: December 24, 2008
Last updated: July 15, 2010
Last verified: July 2010
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Santen SAS:

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

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 ]

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
Drug: NOVA22007


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00814515

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

Responsible Party: Mourad AMRANE, MD, Novagali Pharma Identifier: NCT00814515     History of Changes
Other Study ID Numbers: NVG06C103
Study First Received: December 24, 2008
Last Updated: July 15, 2010

Keywords provided by Santen SAS:

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
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 processed this record on May 22, 2017