Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

InSite Vision

ClinicalTrials.gov Identifier:

NCT01387464

First received: June 29, 2011

Last updated: July 19, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2011
Last Updated Date	July 19, 2012
Start Date ^ICMJE	July 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 1, 2011)	Anterior chamber paracentesis [ Time Frame: approximately 3 hours post last dose ] [ Designated as safety issue: No ] Mean aqueous humor concentrations of bromfenac for the 2 treatment arms will be statistically compared.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01387464 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	Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
Official Title ^ICMJE	A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™ Once Daily (QD) Prior To Cataract Surgery
Brief Summary	The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Cataract
Intervention ^ICMJE	Drug: ISV-303 % of Bromfenac in DuraSite dosed QD Drug: Bromday™ Bromday™ (0.09% Bromfenac) dosed QD
Study Arm (s)	Experimental: ISV-303 Intervention: Drug: ISV-303 Active Comparator: Bromday™ Intervention: Drug: Bromday™
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	60
Completion Date	September 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months. Signature of the subject on the Informed Consent Form Willing and able to follow all instructions and attend all study visits Able to self-administer study drug (or have a caregiver available to instill all doses of study drug) Exclusion Criteria: Use of any drug containing bromfenac within 2 weeks prior to surgery Contact lens wear during the dosing period Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications Any serious complications with or macroscopic damage to the corneal epithelium Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test Currently suffer from alcohol and/or drug abuse Prior participation in this study protocol Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01387464
Other Study ID Numbers ^ICMJE	C-11-303-002
Has Data Monitoring Committee	No
Responsible Party	InSite Vision
Study Sponsor ^ICMJE	InSite Vision
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	InSite Vision
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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