Clinical trial NCT00840580: Effect on Wound Healing of Vigamox Versus Cravit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract Extraction
Keywords: Cataract, Cornea, Vigamox, Cravit
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 79
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of patients with epithelial defect
timeFrame: Day 1, Day 2, Day 3, Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Severance Hospital, Yousei University College of Medicine
name: Eung Kweon Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han KE, Chung WS, Kim TI, Kim S, Kim T, Kim EK. Epithelial wound healing after cataract surgery comparing two different topical fluoroquinolones. Yonsei Med J. 2014 Jan;55(1):197-202. doi: 10.3349/ymj.2014.55.1.197.