Effect on Wound Healing of Vigamox Versus Cravit - Full Text View

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00840580

Purpose

Compare the effect on wound healing as measured by cornea epithelial defect evaluation of Vigamox and Cravit in patients with cataract surgery in market use.

Condition	Intervention	Phase
Cataract Extraction	Drug: Vigamox or Cravit	Phase IV

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 Corneal Disorders

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Definite healing time after surgery. [ Time Frame: Up to 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Wound leak post operation; Width of corneal defect (optional); Punctate corneal epitheliopathy during postoperative day 1-4; Corneal epithelial defect persisting after post operative day 4; Cornea staining score; Visual acuity [ Time Frame: Up to 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active group Vigamox (Moxifloxacin 0.5% Ophthalmic Solution)	Drug: Vigamox or Cravit Patients will be randomized to either the Vigamox arm or the Cravit arm.
Active Comparator: Control group Cravit (Levofloxacin 0.5% Ophthalmic Solution)	Drug: Vigamox or Cravit Patients will be randomized to either the Vigamox arm or the Cravit arm.

Eligibility

Ages Eligible for Study:	20 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

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

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:	Hyesung Shin/Clinical Research Associate, Alcon Korea Ltd.
ClinicalTrials.gov Identifier:	NCT00840580 History of Changes
Other Study ID Numbers:	SMA-08-22
Study First Received:	February 9, 2009
Last Updated:	January 7, 2010
Health Authority:	Korea: Food and Drug Administration

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 February 09, 2012