Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Sponsor

Bp Consulting, Inc (Other)

Overall Status

Completed

CT.gov ID

NCT00595543

Collaborator

(none)

166

Enrollment

Location

Arms

Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pseudophakic Cystoid Macular Edema	Drug: Bromfenac Drug: Ketorolac Drug: Diclofenac	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Bromfenac 1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
Active Comparator: 2	Drug: Ketorolac 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Active Comparator: 3	Drug: Diclofenac 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Bromfenac

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

Active Comparator: 2

Drug: Ketorolac

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

Active Comparator: 3

Drug: Diclofenac

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

Outcome Measures

Primary Outcome Measures

Acute Pseudophakic Cystoid Macular Edema [5 months]

Secondary Outcome Measures

Visual Acuity [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soll Eye Associates	Philadelphia	Pennsylvania	United States	19124

Sponsors and Collaborators

Bp Consulting, Inc

Investigators

Principal Investigator: David Rho, MD, Soll Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00595543

Other Study ID Numbers:

5349

First Posted:

Jan 16, 2008

Last Update Posted:

Mar 19, 2009

Last Verified:

Mar 1, 2009

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2009