Effect on Wound Healing of Vigamox Versus Cravit | NCT00840580

NCT00840580

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox)
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.	Drug: Levofloxacin 0.5% ophthalmic solution (Cravit)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxifloxacin 0.5% ophthalmic solution (Vigamox)	Drug	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.

Measure	Description	Time Frame
Percentage of patients with epithelial defect	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.	Day 1, Day 2, Day 3, Day 10

Eligibility Module

Eligibility Criteria

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.

ID	Term
D002386	Cataract
D003316	Corneal Diseases

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases