NCT00438243

Brief Summary

This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision. The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. The investigators want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

February 21, 2007

Last Update Submit

July 1, 2016

Conditions

Cystoid Macular Edema

Keywords

Pseudophakic macular edema

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects improving >/= 10 letter (2 lines) of best-corrected distance visual acuity at day 90 ± 14 days after initiation of one of the test agents.

    6 months

Secondary Outcomes (2)

  • Analysis of the decrease in the center point retinal thickness by Optical Coherence Tomography (OCT) at 90 ± 14 days after initiation of the test agent.

    6 months

  • Analysis of patient comfort during the use of test agent as assessed with the ocular comfort grading scale

    6 months

Study Arms (2)

1

PLACEBO COMPARATOR

1 drop affected eye twice daily.

Drug: Refresh Plus

2

EXPERIMENTAL

Bromfenac (Xibrom) 1 drop to affected eye twice a day.

Drug: Bromfenac (Xibrom)

Interventions

Bromfenac (Xibrom)DRUG

1 drop to affected eye twice daily.

2
Refresh PlusDRUG

1 drop in the affected eye twice daily

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (ages 18 years or older)
  • Best-corrected visual acuity 20/40 or worse
  • Pseudophakic CME in the study eye with onset at least three weeks and no more than four months after cataract surgery, as document on fluorescein angiography and/or OCT (central subfield \>/= 250 microns)
  • Agree to avoid disallowed medications (including ocular, topical, or systemic NSAIDs; ocular, topical, or systemic corticosteroids; ocular prostaglandin analogs) throughout the duration of the study. Agree to a 14 day washout period prior to enrollment if currently using a disallowed medication.

You may not qualify if:

  • History of a known hypersensitivity to bromfenac, or any component of the test agents and/or "procedural" medications (such as anesthetic, dilating drops, fluorescein, etc)
  • History of pre-existing macular disease that confounds and/or precludes the evaluation of cystoid macular edema (including but not limited to macular hole, epiretinal membrane with pseudohole, diabetic macular edema, neovascular age-related macular degeneration, acute posterior uveitis)
  • CME due to other etiologies such as vein occlusion
  • Use of a topical ophthalmic prostaglandin analog within 14 days prior to enrollment, i.e., the subject does not agree to a 14 day washout period prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Alisa Kim, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

May 1, 2008

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

US(1)