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

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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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Maine Eye Care, PA

Lewiston, Maine, 04240, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOVA22007 ''Cyclosporine''

Drug

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

vehicle/placebo

Drug

vehicle/placebo

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

Sponsors and collaborators

Lead sponsor

Santen SAS

Industry

Registry information

Official study title

A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 21, 2008
Registry last updated: Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed