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CompletedNCT01387464Updated Nov 19, 2021Results posted

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

A Phase 2 interventional study of ISV-303 and Bromday™ in Cataract, sponsored by Sun Pharmaceutical Industries Limited. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Sun Pharmaceutical Industries Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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Keywords

  • bromfenac concentrations
  • ISV-303
  • Bromday
03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 1,171 interventional studies indexed under Cataract.

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Lead sponsor

Sun Pharmaceutical Industries Limited is the lead sponsor of 60 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    ISV-303

    Drug: ISV-303

  • Active comparator
    Bromday™

    Drug: Bromday™

Interventions

  • DrugISV-303

    0.075% bromfenac in DuraSite dosed QD

  • DrugBromday™

    0.09% bromfenac dosed QD

06

What researchers measure

Primary outcomes

  1. Mean Aqueous Humor Bromfenac Concentration

    Time frame: Approximately 3 hours post last dose

07

Results

Posted Jun 2, 2016

Participant flow

Participant flow — Overall Study
MilestoneISV-303Bromday
Started3030
Safety population3029
Per-protocol population2929
Completed2929
Not completed11

Outcome measures

PrimaryMean Aqueous Humor Bromfenac Concentration
Time frame:
Approximately 3 hours post last dose
Reported as:
Mean · ng/mL
Mean Aqueous Humor Bromfenac Concentration
ng/mLISV-303Bromday
Mean Aqueous Humor Bromfenac Concentration49.3 ± 41.8723.7 ± 16.31

Adverse events

Collected over 4 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ISV-303—0/30 (0%)0/30 (0%)
Bromday—0/29 (0%)0/29 (0%)

Baseline characteristics

Intent-to-treat Population

Age, Continuous
Age, Continuous(years)ISV-303BromdayTotal
Mean70.6 ± 10.1468.2 ± 9.569.4 ± 9.8
Age, Customized
Age, Customized(participants)ISV-303BromdayTotal
18-30 years000
31-50 years101
51-70 years101828
>70 years191231
Sex: Female, Male
Sex: Female, Male(Participants)ISV-303BromdayTotal
Female121931
Male181129
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01387464
Lead sponsor
Sun Pharmaceutical Industries Limited
Responsible party
Sponsor
First posted
Jul 4, 2011
Start date
Jul 2011
Primary completion
Aug 2011
Completion
Aug 2011
Results posted
Jun 2, 2016
Last update
Nov 19, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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