Effect on Wound Healing of Vigamox Vers… | Clinical Trial

Key information

Conditions

Cataract Extraction Cataract Corneal Diseases Eye Diseases Lens Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, 120-725, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Vigamox

Levofloxacin 0.5% ophthalmic solution (Cravit)

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.

Other names: Cravit

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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2009
First posted: Feb 10, 2009
Registry last updated: Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed