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

Santen

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Dry Eye Syndrome

Treatments: Drug: NOVA22007 (Ciclosporin 0.1%); Drug: NOVA22007

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814515

NVG06C103

Details and patient eligibility

About

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

Enrollment: 482 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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482 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Ciclosporin 0.1%

Treatment:

Drug: NOVA22007 (Ciclosporin 0.1%)

2

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: NOVA22007