Cataract Extraction
Conditions
Keywords
Cataract, Cornea, Vigamox, Cravit
Brief summary
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.
Interventions
DRUGMoxifloxacin 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.
DRUGLevofloxacin 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.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed