NCT00595543

Brief Summary

To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

January 7, 2008

Last Update Submit

March 17, 2009

Conditions

Acute Pseudophakic Cystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Acute Pseudophakic Cystoid Macular Edema

    5 months

Secondary Outcomes (1)

  • Visual Acuity

    5 months

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Bromfenac

2

ACTIVE COMPARATOR
Drug: Ketorolac

3

ACTIVE COMPARATOR
Drug: Diclofenac

Interventions

BromfenacDRUG

1 drop (in the eye) Instill one drop in the affected eye twice daily for three months

1
KetorolacDRUG

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

2
DiclofenacDRUG

1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

3

Eligibility Criteria

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

You may qualify if:

  • Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
  • Males and females 18 years and older
  • Able to provide written informed consent

You may not qualify if:

  • Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
  • Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
  • History of Uveitis
  • Ipsilateral intraocular surgery prior to cataract surgery
  • CME greater than one year duration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soll Eye Associates

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Interventions

bromfenacKetorolacDiclofenac

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • David Rho, MD

    Soll Eye Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

US(1)