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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Cyclosporine 0.05%

Group Type EXPERIMENTAL

NOVA22007 ''Cyclosporine''

Intervention Type DRUG

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

2

Cyclosporine 0.1%

Group Type EXPERIMENTAL

NOVA22007 ''Cyclosporine''

Intervention Type DRUG

Cyclosporine 0.1% Ophthalmic Cationic Emulsions

3

vehicle/placebo

Group Type PLACEBO_COMPARATOR

vehicle/placebo

Intervention Type DRUG

vehicle/placebo

Interventions

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NOVA22007 ''Cyclosporine''

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

Intervention Type DRUG

NOVA22007 ''Cyclosporine''

Cyclosporine 0.1% Ophthalmic Cationic Emulsions

Intervention Type DRUG

vehicle/placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No