Effect on Wound Healing of Vigamox Versus Cravit

Phase 4

Completed

• Conditions: Cataract Extraction
• Interventions: Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox); Drug: Levofloxacin 0.5% ophthalmic solution (Cravit)

• Registration Number: NCT00840580
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Primary Completion: 2009-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigamox	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.
Cravit	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with epithelial defect	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.