Evaluation of Ocular Comfort With ISTA Tears vs Systane

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01650584

First received: July 24, 2012

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2012

Last Updated Date

January 3, 2013

Start Date ^ICMJE

June 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ocular comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01650584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

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

Evaluation of Ocular Comfort With ISTA Tears vs Systane

Official Title ^ICMJE

Not Provided

Brief Summary

To evaluate the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED). There will also be an assessment of changes in ocular surface disease index (OSDI) score along with changes in worse symptom.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Dry Eye Disease

Intervention ^ICMJE

Drug: ISTA Tears
sterile ophthalmic solution
Drug: Systane
Sterile ophthalmic solution

Study Arm (s)

Experimental: ISTA Tears
Sterile ophthalmic solution

Intervention: Drug: ISTA Tears
Active Comparator: Systane
Sterile ophthalmic solution

Intervention: Drug: Systane

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

OSDI >12

Exclusion Criteria:

Presence of any active ocular disease other than dry eye

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

NCT01650584

Other Study ID Numbers ^ICMJE

S00231

Has Data Monitoring Committee

Responsible Party

Bausch & Lomb Incorporated

Study Sponsor ^ICMJE

Bausch & Lomb Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tim McNamara, PharmD

ISTA Pharmaceuticals, Inc.

Information Provided By

Bausch & Lomb Incorporated

Verification Date

January 2013

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

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