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Effect on Wound Healing of Vigamox Versus Cravit

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ClinicalTrials.gov Identifier: NCT00840580
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.

Condition or disease Intervention/treatment Phase
Cataract Extraction Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox) Drug: Levofloxacin 0.5% ophthalmic solution (Cravit) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study Comparing Effect on Wound Healing of Vigamox (Moxifloxacin 0.5% Ophthalmic Solution) and Cravit (Levofloxacin 0.5% Ophthalmic Solution) Administered Post-Surgically in Patients Undergoing Cataract Extraction
Study Start Date : January 2009
Actual Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vigamox
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
 Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox)
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
Other Name: Vigamox
Active Comparator: Cravit
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
 Drug: Levofloxacin 0.5% ophthalmic solution (Cravit)
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
Other Name: Cravit


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with epithelial defect [ Time Frame: Day 1, Day 2, Day 3, Day 10 ]
    The eye was imaged. An epithelial defect was defined as a non-continuous epithelium. The eye was considered healed when the defect was no longer visible.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of any race and either sex, and over the age of 18, who are scheduled for removal of a cataract and implantation of a posterior chamber intraocular lens using clear corneal incisions or near-clear corneal incisions.
  • Intraocular pressure (IOP) readings, treated or untreated, less than or equal to 20 mmHg prior to surgery. Glaucoma patients are eligible if an ocular hypotensive agent (only one) controls their IOP.
  • Other than cataracts, have normal healthy eyes as determined by the ophthalmic examination and case history.
  • Subconjunctival injections right after cataract surgery are allowed.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any cataract wound that is stitched or any gross abrasion of the epithelium after removal of a cataract and implantation of a posterior chamber intraocular lens.
  • Fluorescein staining of the cornea at baseline.
  • History or evidence of ocular or systemic disease, which would preclude participation in this study. Examples could include autoimmune disease affecting the cornea as well as any corneal dystrophies.
  • History of ocular inflammatory disease, ocular herpes infection, iritis, uveitis, or Sjögren's syndrome.
  • Known or suspected allergy or hypersensitivity to levofloxacin or any related medicines, such as cinoxacin (Cinobac), ciprofloxacin (Cipro or Ciloxan), norfloxacin (Chibroxin or Noroxin), ofloxacin (Floxin), or nalidixic acid (NegGram), preservatives, dyes, or any components of the study medication.
  • Treatment for an ocular infection within 30 days prior to study entry.
  • Use of topical or systemic steroids within 7 days prior to study entry.
  • Use of topical anti inflammatory drugs within 7 days prior to study entry.
  • Pregnancy, nursing/lactation, or inadequate birth control methods. Oral contraceptives are allowed.
  • Patients with uncontrolled diabetes and/or diabetic retinopathy.
  • No ointment is used after cataract surgery.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840580


Locations
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Korea, Republic of
Seoul, Korea, Republic of, 120-725
Sponsors and Collaborators
Alcon Research
Investigators
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Principal Investigator: Eung Kweon Kim, MD/PhD Severance Hospital, Yousei University College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00840580    
Other Study ID Numbers: SMA-08-22
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012
Keywords provided by Alcon Research:
Cataract, Cornea, Vigamox, Cravit
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Moxifloxacin
Levofloxacin
Ofloxacin
Pharmaceutical Solutions
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Anti-Infective Agents, Urinary
Renal Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors