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

Santen SAS132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Dry Eye

Interventions

NOVA22007 ''Cyclosporine''DRUG

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

NOVA22007 ''Cyclosporine''DRUG

Cyclosporine 0.1% Ophthalmic Cationic Emulsions

vehicle/placeboDRUG

vehicle/placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Central Maine Eye Care, PA

Lewiston, Maine, United States

Outcomes

Primary Outcomes

Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions

Time frame: Approximately 13 weeks

Data from ClinicalTrials.gov

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