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Trial record 5 of 34 for:    Open Studies | "Eye Infections"

Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Adapt Produtos Oftalmológicos Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01603030
First received: March 22, 2011
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Eye Infection/Inflammation Other
Drug: moxifloxacin 0,5% + prednisolone 1%
Drug: moxifloxacin/prednisolone combination
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:

Primary Outcome Measures:
  • Day 15 Evaluation of Anterior Chamber [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • day 15 physician´s follow-up impression of inflammatory reaction score [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 66
Study Start Date: June 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: moxifloxacin/prednisolone combination
1 gtt, 4x/day, 15 days
Drug: moxifloxacin/prednisolone combination
1 gtt, 4x/day, 15 days
Other Name: 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 Name: moxifloxacin 0,5%, prednisolone 1%

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01603030

Contacts
Contact: Rubens Belfort, investigator 5511 5572-6443 prof.belfort@clinicabelfort.com.br
Contact: Cristina Mucioli, coordinator 55115572-6443 crissmucci@gmail.com

Locations
Brazil
Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP Not yet recruiting
São Paulo, SP/Brazil, Brazil, 4562-020
Contact: Rubens Belfort, investigator    55115572-6443    prof.belfort@clinicabelfort.com.br   
Contact: Luci Silva, coordinator    55115572-6443    luci@oftalmo.epm.br   
Principal Investigator: Rubens Belfort, MD         
Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Investigators
Study Chair: Cristina Mucioli, Dra. Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
  More Information

No publications provided

Responsible Party: Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier: NCT01603030     History of Changes
Other Study ID Numbers: ADAMOXPRE01/10
Study First Received: March 22, 2011
Last Updated: May 21, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
Moxifloxacin
Prednisolone
LASIK

Additional relevant MeSH terms:
Eye Infections
Inflammation
Eye Diseases
Infection
Pathologic Processes
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on November 25, 2014