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

Sun Pharma

Status and phase

Completed

Phase 2

Conditions

Cataract

Treatments

Drug: ISV-303

Drug: Bromday™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387464

C-11-303-002

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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