A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT01212471

First received: September 28, 2010

Last updated: March 14, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 28, 2010

Last Updated Date

March 14, 2013

Start Date ^ICMJE

September 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sign and symptom measures of dry eye disease [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01212471 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

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Official Title ^ICMJE

Not Provided

Brief Summary

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye Syndrome

Intervention ^ICMJE

Drug: Bromfenac Ophthalmic Solution A
sterile ophthalmic solution
Drug: Bromfenac Ophthalmic Solution B
sterile ophthalmic solution
Drug: Placebo Comparator
sterile ophthalmic solution

Study Arm (s)

Experimental: Bromfenac Ophthalmic Solution A
Bromfenac ophthalmic solution A

Intervention: Drug: Bromfenac Ophthalmic Solution A
Experimental: Bromfenac Ophthalmic Solution B
Bromfenac ophthalmic solution B

Intervention: Drug: Bromfenac Ophthalmic Solution B
Placebo Comparator: Placebo Comparator
Placebo Comparator

Intervention: Drug: Placebo Comparator

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

Enrollment ^ICMJE

840

Completion Date

December 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Be of either gender and any race 18 years or older

Exclusion Criteria:

Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

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

NCT01212471

Other Study ID Numbers ^ICMJE

S00007

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

March 2013

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

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