Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation

Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery

This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK surgery.

Study Overview

• Status: Unknown
• Conditions: Eye Infection/Inflammation Other
• Intervention / Treatment: Drug: moxifloxacin/prednisolone combination; Drug: moxifloxacin 0,5% + prednisolone 1%

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP/Brazil
    • São Paulo, SP/Brazil, Brazil, 4562-020
      • Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women of any race, between 18 and 50 years of age up to 8 degrees of myopia or hyperopia of up to 04 degrees or up to 3 degrees without astigmatism and other eye problems associated.
• Able to understand and provide informed consent,
• Willingness to complete all required study visits,
• Willingness to undergo surgery to correct grade (myopia, astigmatism, hyperopia) by LASIK in both eyes (at the same surgical or surgical procedures separated) or in only one eye.
• Examination of normal fundus by direct ophthalmoscopy or indirect;
• Measurements of intraocular pressure (IOP), treated or untreated, less than or equal to 20 mmHg. Individuals with glaucoma / ocular hypertension are eligible if their blood pressure is controlled by a single ocular hypotensive agent with the exception noted in criterion of exclusion. 16.
• Women who may become pregnant (those that are not surgically sterile or postmenopausal) may participate in the study if they meet all the following conditions: a)not breastfeeding; b)have a negative pregnancy test at screening prior to recruitment; c)agree to submit to a urine test for pregnancy at the time of its withdrawal from the study; d)not to conceive during the study period; e)are using birth control methods appropriate and agrees to continue to use birth control methods appropriate for the duration of the study (the methods of birth control are adequate: hormonal contraceptives - oral, implantable or injectable; mechanics - spermicide associated with a barrier method like a condom or diaphragm, IUD, or sterilization of the partner).

Exclusion Criteria:

• Glaucoma or intraocular hypertension not controlled;
• Use of nonsteroidal antiinflammatory drugs (NSAIDs) ocular topical or systemic drugs (NSAIDs) during the study and the 14 days prior to study entry, except for an allowed daily dose of aspirin low-dose (100 mg);
• Ocular anti-infective drug use during the study and within 30 days prior to study entry or any other eye medicines with the exception noted in criterion Insertion 6.
• Topical steroids, inhaled or systemic ocular during the study and the 14 days prior to study entry;
• Ocular trauma in the eye prior to operate (including intraocular surgery in the previous twelve months due to trauma or cataract in the past);
• History of chronic ocular inflammatory disease or recurrent (ie, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the eye to be operated;
• Any intraocular inflammation (score of cells than Grade 0) to be present during the examination of slit lamp or ocular pain increased in the Grade 1 -2 Day in the study eye (eye operation);
• Proliferative diabetic retinopathy (eye operation) non-proliferative diabetic retinopathy, moderate to severe (eye operation);
• Uncontrolled diabetes mellitus;
• Patients with vision in one eye or vision not correctable to LogMAR 1.0 or better in each eye using the ETDRS framework;
• Participation in any other clinical study within 12 months prior to surgery, pregnant women, lactating or under conditions of breeding methods that are not using adequate birth control (as defined in the criteria for inclusion, above);
• Known or suspected allergy or hypersensitivity to moxifloxacin, steroids, topical anesthetics or any other component of the study medication;
• History or other evidence of severe illness, or other systemic conditions that may cause the patient, in the opinion of the Investigator, the study is inadequate;
• Patients with epithelial herpes simplex (dendritic keratitis), vaccinia, varicella, or other viral disease of the cornea or conjunctiva, tuberculosis of the eye, fungal diseases of ocular structures;
• Patients who use a topical ophthalmic prostaglandin, such as ,Travatan® (travoprost),Xalatan®(latanoprost),Lumigan®(bimatoprost)and Rescula®(unoprostone) should discontinue their use starting four days before surgery until their departure from study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: moxifloxacin/prednisolone combination; 1 gtt, 4x/day, 15 days	Drug: moxifloxacin/prednisolone combination; 1 gtt, 4x/day, 15 days; Other Names: moxifloxacin 0,5%; predfort
Active Comparator: moxifloxacin 0,5% + Prednisolone 1%; 1 drop of each bottle, BID, 15 days	Drug: moxifloxacin 0,5% + prednisolone 1%; 1 gtt, 4x/day, 15 days; Other Names: moxifloxacin 0,5%, prednisolone 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 15 Evaluation of Anterior Chamber	The primary efficacy variable of this study is the percentage of patients with a score of zero postoperative inflammation (anterior chamber inflammation, ie, presence of cells in the anterior chamber (0-4) in the study on Day 15. The absence of bacterial infection on Day 15 ± 1 will be assumed to demonstrate that the antibacterial agents in the association of moxifloxacin / acetate Prednisolona1% and moxifloxacin + acetate Prednisolona1% Eye drops are equal in antimicrobial effectiveness, and that they acted in a prophylactic manner to prevent of bacterial infection.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
day 15 physician´s follow-up impression of inflammatory reaction score	the clinical evaluation will be based on the following variables: IOP, assessment of visual acuity, slit lamp examination (lids, conjunctiva, cornea), and examination of the fundus (retina / macula / choroid, vitreous and optic nerve).	15 days

Collaborators and Investigators

• Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Investigators: Study Chair: Cristina Mucioli, Dra., Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: March 22, 2011
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 22, 2012

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Prednisolone; LASIK; Moxifloxacin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Eye Diseases; Inflammation; Eye Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: ADAMOXPRE01/10