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

July 15, 2010 updated by: Santen SAS

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

482

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Île-de-France
      • Paris, Île-de-France, France, 75012
        • Hôpital des XV-XX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Vehicle
Drug: NOVA22007
Vehicle
ACTIVE_COMPARATOR: 1
Ciclosporin 0.1%
Drug: NOVA22007 (Ciclosporin 0.1%)
Ciclosporin 0.1% Ophthalmic Emulsions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal fluorescein staining (on modified Oxford scale)
Time Frame: Approximately 26 weeks
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
Approximately 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
• 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
Approximately 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

December 24, 2008

First Posted (ESTIMATE)

December 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2010

Last Update Submitted That Met QC Criteria

July 15, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVG06C103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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