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

Ocular Infection and Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218737
• Other study ID #: AG9890X-001
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: March 19, 2018
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Eye Infections
• Infection
• Inflammation
• Ocular Infection and Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Dept of Ophthalmology	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Allergan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.		Day 15