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
1 other identifier
interventional
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMay 22, 2012
May 1, 2012
2 months
March 22, 2011
May 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
day 15 physician´s follow-up impression of inflammatory reaction score
15 days
Study Arms (2)
moxifloxacin/prednisolone combination
EXPERIMENTAL1 gtt, 4x/day, 15 days
moxifloxacin 0,5% + Prednisolone 1%
ACTIVE COMPARATOR1 drop of each bottle, BID, 15 days
Interventions
1 gtt, 4x/day, 15 days
1 gtt, 4x/day, 15 days
Eligibility Criteria
You may qualify if:
- 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;
- 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).
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
São Paulo, SP/Brazil, 4562-020, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cristina Mucioli, Dra.
Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
May 22, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
May 22, 2012
Record last verified: 2012-05