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

NCT01387464 | Completed Phase 2 Results

• 1 other identifier: C-11-303-002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

bromfenac concentrations; ISV-303; Bromday

Outcome Measures

Primary Outcomes (1)

• Mean Aqueous Humor Bromfenac Concentration

  Approximately 3 hours post last dose

Study Arms (2)

ISV-303

EXPERIMENTAL

Drug: ISV-303

Bromday™

ACTIVE COMPARATOR

Drug: Bromday™

Interventions

ISV-303 DRUG

0.075% bromfenac in DuraSite dosed QD

ISV-303

Bromday™ DRUG

0.09% bromfenac dosed QD

Bromday™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

MeSH Terms

Conditions

Cataract

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Manager, Clinical Sciences
• Organization: InSite Vision

manjiri.desai@sparcmail.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 4, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 19, 2021
• Results First Posted: June 2, 2016

Record last verified: 2021-11