Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

This study has been completed.

Sponsor:

Information provided by:

Innovative Medical

ClinicalTrials.gov Identifier:

NCT00405457

First received: November 28, 2006

Last updated: February 19, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2006

Last Updated Date

February 19, 2010

Start Date ^ICMJE

November 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

efficacy [ Time Frame: 1 yr 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00405457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

dry eye symptoms [ Time Frame: 1 yr 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Official Title ^ICMJE

Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Brief Summary

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye

Intervention ^ICMJE

Drug: Restasis, Optive Tears

Restasis and Optive Tears use twice daily more frequently if needed

Study Arm (s)

Intervention: Drug: Restasis, Optive Tears

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

· Males or females > 18 years old
- Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
- Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

· Patients using Restasis® for less than 3 months.
- Known contraindications to any study medication or ingredients
- Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- Other active uncontrolled ocular diseases or uncontrolled systemic disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00405457

Other Study ID Numbers ^ICMJE

5261

Has Data Monitoring Committee

Not Provided

Responsible Party

David Hardten, MD, Minnesota Eye Consultants

Study Sponsor ^ICMJE

Innovative Medical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Hardten, MD

Minnesota Eye Consultants

Information Provided By

Innovative Medical

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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