Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00330824
First received: May 26, 2006
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK


Condition Intervention
Post Lasik Surgery Inflammation
Drug: antibiotic/steroid combination
Drug: moxifloxacin/dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • day 15 evaluation of anterior chamber [ Time Frame: 15 days pos-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score [ Time Frame: 15 days pos-op ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antibiotic steroid (single vial)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
Drug: antibiotic/steroid combination
1gtt, 4x/d, 15 days
Other Name: moxifloxacin/dexamethasone
Active Comparator: antibiotic / steroid (2 vials)
efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery
Drug: moxifloxacin/dexamethasone
1gtt, 4x/days, 15 days
Other Name: moxifloxacin / dexamethasone

Detailed Description:

antibiotic/steroid combination compared to individuals components 15 days of treatment

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients having LASIK surgery;
  • men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330824

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

No publications provided

Responsible Party: Rubens Belfort Jr, Head Professor of Ophthalmology
ClinicalTrials.gov Identifier: NCT00330824     History of Changes
Other Study ID Numbers: BRA-05-02
Study First Received: May 26, 2006
Last Updated: August 6, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
prevention of post inflammation in LASIK surgery

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antitubercular Agents
Autonomic Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014