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Effect on Wound Healing of Vigamox Versus Cravit

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract Extraction

Intervention: Moxifloxacin 0.5% ophthalmic solution (Vigamox) (Drug); Levofloxacin 0.5% ophthalmic solution (Cravit) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Eung Kweon Kim, MD/PhD, Principal Investigator, Affiliation: Severance Hospital, Yousei University College of Medicine


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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of patients with epithelial defect


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Seoul 120-725, Korea, Republic of
Additional Information

Starting date: January 2009
Last updated: July 19, 2012

Page last updated: August 23, 2015

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