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CompletedNCT00330824Updated Aug 7, 2009

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

An interventional study of antibiotic/steroid combination and moxifloxacin/dexamethasone in Post Lasik Surgery Inflammation, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-08-07.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Post Lasik Surgery Inflammation

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Keywords

  • prevention of post inflammation in LASIK surgery
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 64 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Drugantibiotic/steroid combination

    1gtt, 4x/d, 15 days

    Also known as: moxifloxacin/dexamethasone

  • Drugmoxifloxacin/dexamethasone

    1gtt, 4x/days, 15 days

    Also known as: moxifloxacin / dexamethasone

06

What researchers measure

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

07

Study locations

1 site
  • Dept. of Ophthalmology - Rua Botucatu 824
    São paulo, SP 04023-062, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00330824
Lead sponsor
Federal University of São Paulo
First posted
May 29, 2006
Start date
Apr 2006
Primary completion
Sep 2006
Completion
Dec 2006
Last update
Aug 7, 2009

Study contacts

Rubens Belfort Jr, MD, PhD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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