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Trial record 18 of 19 for:    "Lens Disease" | "Estradiol"

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

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ClinicalTrials.gov Identifier: NCT00331084
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : August 7, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

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

Condition or disease Intervention/treatment Phase
Inflammation Following Cataract Surgery Drug: antibiotic/steroid combination Drug: moxifloxacin / dexamethasone Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery
Study Start Date : April 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Cataract

Arm Intervention/treatment
Experimental: antibiotic steroid drops/single vial
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Drug: antibiotic/steroid combination
1 gtt, 4x/day, 15 days
Other Name: moxifloxacin / dexamethasone

Active Comparator: antibiotic steroids drops
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery
Drug: moxifloxacin / dexamethasone
1 gtt 4x/day, 15 days




Primary Outcome Measures :
  1. day 15 evaluation of anterior chamber [ Time Frame: 15 days pos-op ]

Secondary Outcome Measures :
  1. day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score [ Time Frame: 15 days pos-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331084


Locations
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Brazil
Dept of Opthalmology - Rua Botucatu 824
São Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Rubens Belfort Jr, MD, PhD Federal University of São Paulo

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Responsible Party: Rubens Belfort Jr, Head Professor of Ophthalmology
ClinicalTrials.gov Identifier: NCT00331084     History of Changes
Other Study ID Numbers: BRA-05-01
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009
Keywords provided by Federal University of São Paulo:
prevention of post inflammation in cataract surgery
Additional relevant MeSH terms:
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Lens Diseases
Norgestimate, ethinyl estradiol drug combination
Cataract
Inflammation
Pathologic Processes
Eye Diseases
Anti-Bacterial Agents
Moxifloxacin
Antibiotics, Antitubercular
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors