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Completed

NCT Number: NCT01808547

Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

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Key information

Conditions

Ocular Inflammation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
  • If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. 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 to avoid disallowed medications for the duration of the study
  • Willing and able to follow all instructions and attend all study visits
  • Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
  • Additional inclusion criteria also apply

Exclusion criteria

  • Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
  • Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
  • Currently suffer from alcohol and/or drug abuse
  • 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
  • Additional inclusion criteria also apply

Treatment and study plan

ISV-303

Drug

0.075% bromfenac in DuraSite dosed BID

DuraSite Vehicle

Other

DuraSite vehicle dosed BID

Primary outcomes

  1. Ocular Inflammation

    Time frame: 15 days

    Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study title

A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 11, 2013
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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