Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

NCT ID: NCT00758199

Last Updated: 2012-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

Brief Summary

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The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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2

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin hydrochloride

Intervention Type DRUG

Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.

3

Prednisolone Acetate

Group Type PLACEBO_COMPARATOR

Prednisolone Acetate

Intervention Type DRUG

Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).

1

Bromfenac

Group Type ACTIVE_COMPARATOR

Bromfenac

Intervention Type DRUG

Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks

Interventions

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Bromfenac

Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks

Intervention Type DRUG

Moxifloxacin hydrochloride

Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.

Intervention Type DRUG

Prednisolone Acetate

Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).

Intervention Type DRUG

Other Intervention Names

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Bromfenac (Xibrom) Moxifloxacin hydrochloride (Vigamox) Omni-Pred

Eligibility Criteria

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Inclusion Criteria

* Male or female \>18 years of age scheduled to undergo bilateral cataract surgery
* Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
* Expected visual outcome of BCVA \> \[greater than or equal to\] 20/30 postoperatively
* Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion Criteria

* Known contraindication to any study medication or any of their components
* Required use of ocular medications other than the study medications during the study
* Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
* Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
* Anticipated need for mechanical iris dilating devices
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bp Consulting, Inc

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altos Eye Physicians

Los Altos, California, United States

Site Status

Countries

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United States

Other Identifiers

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2008-0036

Identifier Type: -

Identifier Source: org_study_id

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