Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01218737
First received: October 8, 2010
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Infection and Inflammation After Refractive Surgery (Lasik).
Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association
Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Association
0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo
Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association

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.

Other Name: Zypred
Active Comparator: Isolated ingredients
0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations
Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate

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.

Other Names:
  • Zymar
  • Pred Fort

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01218737

Locations
Brazil
Federal University of Sao Paulo - Dept of Ophthalmology
Sao Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier: NCT01218737     History of Changes
Other Study ID Numbers: AG9890X-001
Study First Received: October 8, 2010
Last Updated: October 14, 2010
Health Authority: Brazil: National Health Surveillance Agency (ANVISA)

Additional relevant MeSH terms:
Eye Infections
Inflammation
Infection
Eye Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Gatifloxacin
Fluoroquinolones
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014