NCT00840580CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 79
- Primary Endpoint
- Percentage of patients with epithelial defect
Study Overview
Brief Summary
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria may apply.
Arms & Interventions
Vigamox
Experimental
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.
Intervention: Moxifloxacin 0.5% ophthalmic solution (Vigamox) (Drug)
Cravit
Active Comparator
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.
Intervention: Levofloxacin 0.5% ophthalmic solution (Cravit) (Drug)
Outcomes
Primary Outcomes
Percentage of patients with epithelial defect
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 3
A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVOMacular EdemaCentral Retinal Vein OcclusionNCT00567697Aleris Helse32
Unknown
Phase 4
Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading DoseEye InfectionInfectionNCT00347828Ophthalmic Consultants of Boston40
Withdrawn
Phase 2
Vigamox Treatment for Ocular Graft-Versus-Host DiseaseOcular Graft-versus-host DiseaseNCT04204122Washington University School of Medicine
Completed
Phase 4
Dosage Study for Vigamox Eye Drops Prior to Intravitreal InjectionsIntravitreal Injection PatientsNCT00690313Illinois Retina Associates22
Unknown
Not Applicable
Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium ExcisionPrimary PterygiumNCT00892918Meir Medical Center40