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OpenTrials
Completed

NCT Number: NCT00330824

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

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

Completed

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Key information

Conditions

Post Lasik Surgery Inflammation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Ophthalmology - Rua Botucatu 824

São Paulo, 04023-062, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antibiotic/steroid combination

Drug

1gtt, 4x/d, 15 days

Other names: moxifloxacin/dexamethasone

moxifloxacin/dexamethasone

Drug

1gtt, 4x/days, 15 days

Other names: moxifloxacin / dexamethasone

Primary outcomes

  1. day 15 evaluation of anterior chamber

    Time frame: 15 days pos-op

Secondary outcomes

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

    Time frame: 15 days pos-op

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 29, 2006
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.