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

Primary Purpose

Inflammation Following Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
antibiotic/steroid combination
moxifloxacin / dexamethasone
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation Following Cataract Surgery focused on measuring prevention of post inflammation in cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Opthalmology - Rua Botucatu 824

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

antibiotic steroid drops/single vial

antibiotic steroids drops

Arm Description

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

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

Outcomes

Primary Outcome Measures

day 15 evaluation of anterior chamber

Secondary Outcome Measures

day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score

Full Information

First Posted
May 25, 2006
Last Updated
August 6, 2009
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00331084
Brief Title
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery
Official Title
Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Following Cataract Surgery
Keywords
prevention of post inflammation in cataract surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antibiotic steroid drops/single vial
Arm Type
Experimental
Arm Description
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Arm Title
antibiotic steroids drops
Arm Type
Active Comparator
Arm Description
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Intervention Type
Drug
Intervention Name(s)
antibiotic/steroid combination
Other Intervention Name(s)
moxifloxacin / dexamethasone
Intervention Description
1 gtt, 4x/day, 15 days
Intervention Type
Drug
Intervention Name(s)
moxifloxacin / dexamethasone
Intervention Description
1 gtt 4x/day, 15 days
Primary Outcome Measure Information:
Title
day 15 evaluation of anterior chamber
Time Frame
15 days pos-op
Secondary Outcome Measure Information:
Title
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
Time Frame
15 days pos-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Belfort Jr, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Opthalmology - Rua Botucatu 824
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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