Effect on Wound Healing of Vigamox Versus Cravit

NCT ID: NCT00840580

Last Updated: 2012-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

Brief Summary

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

Conditions

Cataract Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Moxifloxacin 0.5% ophthalmic solution (Vigamox)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Levofloxacin 0.5% ophthalmic solution (Cravit)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Vigamox; Cravit

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.

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eung Kweon Kim, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yousei University College of Medicine

Locations

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24339307 (View on PubMed)

Other Identifiers

SMA-08-22

Identifier Type: -

Identifier Source: org_study_id