Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

NCT ID: NCT00331084

Last Updated: 2009-08-07

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

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

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efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Detailed Description

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Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Conditions

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Inflammation Following Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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antibiotic steroid drops/single vial

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Group Type EXPERIMENTAL

antibiotic/steroid combination

Intervention Type DRUG

1 gtt, 4x/day, 15 days

antibiotic steroids drops

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Group Type ACTIVE_COMPARATOR

moxifloxacin / dexamethasone

Intervention Type DRUG

1 gtt 4x/day, 15 days

Interventions

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antibiotic/steroid combination

1 gtt, 4x/day, 15 days

Intervention Type DRUG

moxifloxacin / dexamethasone

1 gtt 4x/day, 15 days

Intervention Type DRUG

Other Intervention Names

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moxifloxacin / dexamethasone

Eligibility Criteria

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Inclusion Criteria

* patients having cataract surgery

Exclusion Criteria

* Uncontrolled glaucoma or intraocular hypertension;
* Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
* A history of chronic or recurrent ocular inflammatory disease;
* Uncontrolled diabetes mellitus and diabetic retinopathy ;
* Patients with sight in a single eye;
* Iris atrophy in the eye to be operated;
* Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
* Known or suspected allergy or hypersensitivity to any component of study medication;
* A history or any other evidence of severe systemic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Head Professor of Ophthalmology

Principal Investigators

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Rubens Belfort Jr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Dept of Opthalmology - Rua Botucatu 824

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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BRA-05-01

Identifier Type: -

Identifier Source: org_study_id

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