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

May 26, 2016 updated by: Santen SAS

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Eye Care, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cyclosporine 0.05%
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
Experimental: 2
Cyclosporine 0.1%
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
Placebo Comparator: 3
vehicle/placebo
Drug: vehicle/placebo
vehicle/placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
Time Frame: Approximately 13 weeks
Approximately 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

May 26, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVG08B112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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