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Effect on Wound Healing of Vigamox Versus Cravit

Primary Purpose

Cataract Extraction

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Moxifloxacin 0.5% ophthalmic solution (Vigamox)

Levofloxacin 0.5% ophthalmic solution (Cravit)

About this trial

This is an interventional treatment trial for Cataract Extraction focused on measuring Cataract, Cornea, Vigamox, Cravit

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vigamox

Cravit

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00840580

First Posted

February 9, 2009

Last Updated

July 19, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00840580

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract Extraction

Keywords

Cataract, Cornea, Vigamox, Cravit

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vigamox

Arm Type

Experimental

Arm Description

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.

Arm Title

Cravit

Arm Type

Active Comparator

Arm Description

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

Intervention Name(s)

Moxifloxacin 0.5% ophthalmic solution (Vigamox)

Other Intervention Name(s)

Vigamox

Intervention Description

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

Intervention Name(s)

Levofloxacin 0.5% ophthalmic solution (Cravit)

Other Intervention Name(s)

Cravit

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of patients with epithelial defect

Description

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.

Time Frame

Day 1, Day 2, Day 3, Day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eung Kweon Kim, MD/PhD

Organizational Affiliation

Severance Hospital, Yousei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

City

Seoul

ZIP/Postal Code

120-725

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24339307

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.

Results Reference

derived

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Effect on Wound Healing of Vigamox Versus Cravit

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