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Completed

NCT Number: NCT00814515

Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) 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

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Key information

Conditions

Moderate to Severe Dry Eye Syndrome Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital des XV-XX

Paris, Île-de-France Region, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NOVA22007 (Ciclosporin 0.1%)

Drug

Ciclosporin 0.1% Ophthalmic Emulsions

NOVA22007

Drug

Vehicle

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Santen SAS

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2008
Registry last updated
Jul 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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