Back to resultsNon-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Primary Purpose
Ocular Infection and Inflammation
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
0.3% gatifloxacin and 1.0% prednisolone acetate association
isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Infection and Inflammation
Eligibility Criteria
Inclusion Criteria:
- Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
- Patient presents a normal eye fundus.
- Patient has intraocular pressure (IOP) ≤ 20 mmHg.
Exclusion Criteria:
- Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
- Patient has diabetes or is immunodepressed.
- Any systemic infection during the study.
- Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
- Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
- Patient has known hypersensitivity to any of the components of the formulations used in the study.
Sites / Locations
- Federal University of Sao Paulo - Dept of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Association
Isolated ingredients
Arm Description
0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo
0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations
Outcomes
Primary Outcome Measures
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT01218737
First Posted
October 8, 2010
Last Updated
March 19, 2018
Sponsor
Federal University of São Paulo
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01218737
Brief Title
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Official Title
Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Infection and Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Association
Arm Type
Experimental
Arm Description
0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo
Arm Title
Isolated ingredients
Arm Type
Active Comparator
Arm Description
0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations
Intervention Type
Drug
Intervention Name(s)
0.3% gatifloxacin and 1.0% prednisolone acetate association
Other Intervention Name(s)
Zypred
Intervention Description
Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
Intervention Type
Drug
Intervention Name(s)
isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
Other Intervention Name(s)
Zymar, Pred Fort
Intervention Description
Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
Primary Outcome Measure Information:
Title
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
Patient presents a normal eye fundus.
Patient has intraocular pressure (IOP) ≤ 20 mmHg.
Exclusion Criteria:
Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
Patient has diabetes or is immunodepressed.
Any systemic infection during the study.
Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
Patient has known hypersensitivity to any of the components of the formulations used in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Sao Paulo - Dept of Ophthalmology
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
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