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

NCT00814515 | Completed Phase 3 DMC

• 1 other identifier: NVG06C103
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

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

Conditions

Moderate to Severe Dry Eye Syndrome

Keywords

Moderate; Severe; Dry; Eye; Ciclosporin; Cyclosporine

Outcome Measures

Primary Outcomes (2)

• Corneal fluorescein staining (on modified Oxford scale)

  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%

  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

  Approximately 26 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclosporin 0.1%

Drug: NOVA22007 (Ciclosporin 0.1%)

2

PLACEBO COMPARATOR

Vehicle

Drug: NOVA22007

Interventions

NOVA22007 (Ciclosporin 0.1%) DRUG

Ciclosporin 0.1% Ophthalmic Emulsions

1

NOVA22007 DRUG

Vehicle

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18 years of age or greater.
• At baseline, moderate to severe dry eye condition persisting despite conventional management.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (1)

Hôpital des XV-XX

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

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

FR (1)