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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387464
• Other study ID #: C-11-303-002
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: November 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• ISV-303
0.075% bromfenac in DuraSite dosed QD
• Bromday™
0.09% bromfenac dosed QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Aqueous Humor Bromfenac Concentration		Approximately 3 hours post last dose