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Effect on Wound Healing of Vigamox Versus Cravit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00840580
First received: February 9, 2009
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of patients with epithelial defect [ Time Frame: Day 1, Day 2, Day 3, Day 10 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 79
Study Start Date: January 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840580

Locations
Korea, Republic of
Seoul, Korea, Republic of, 120-725
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Eung Kweon Kim, MD/PhD Severance Hospital, Yousei University College of Medicine
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00840580     History of Changes
Other Study ID Numbers: SMA-08-22
Study First Received: February 9, 2009
Last Updated: July 19, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Alcon Research:
Cataract, Cornea, Vigamox, Cravit

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013