NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

Santen

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: NOVA22007 ''Cyclosporine''; Drug: vehicle/placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739349

NVG08B112

Details and patient eligibility

About

Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female 18 years and older
• Diagnosis of dry eye in both eyes

Exclusion criteria

• Contraindications to the use of the study medications
• Known allergy or sensitivity to the study medications or their components
• Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
• Have participated in an investigational drug or device study within 30 days of Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Cyclosporine 0.05%

Treatment:

Drug: NOVA22007 ''Cyclosporine''

Drug: NOVA22007 ''Cyclosporine''

2

Experimental group

Description:

Cyclosporine 0.1%

Treatment:

Drug: NOVA22007 ''Cyclosporine''

Drug: NOVA22007 ''Cyclosporine''

3

Placebo Comparator group

Description:

vehicle/placebo

Treatment:

Drug: vehicle/placebo