NCT00840580

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

February 9, 2009

Last Update Submit

July 19, 2012

Conditions

Cataract Extraction

Keywords

Cataract, Cornea, Vigamox, Cravit

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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.

Also known as: Vigamox
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.

Also known as: Cravit
Cravit

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, 120-725, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24339307DERIVED

MeSH Terms

Conditions

CataractCorneal Diseases

Interventions

MoxifloxacinOphthalmic SolutionsLevofloxacin

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsOfloxacin

Study Officials

  • Eung Kweon Kim, MD/PhD

    Severance Hospital, Yousei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

KR(1)