Effect on Wound Healing of Vigamox Versus Cravit

Cataract Extraction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840580
• Other study ID #: SMA-08-22
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2009
• Last updated: July 19, 2012
• Start date: January 2009

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataract Extraction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes