Effect on Wound Healing of Vigamox Versus Cravit

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00840580

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Arms and Interventions

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 Names: 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 Names: Cravit

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 Names:

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 Names:

Cravit

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.