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OpenTrials
Completed

NCT Number: NCT00331084

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

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

Completed

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Key information

Conditions

Inflammation Following Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Opthalmology - Rua Botucatu 824

São Paulo, 04023-062, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

antibiotic/steroid combination

Drug

1 gtt, 4x/day, 15 days

Other names: moxifloxacin / dexamethasone

moxifloxacin / dexamethasone

Drug

1 gtt 4x/day, 15 days

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 Postoperative Inflammation in Patients Having Cataract Surgery

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
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.