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Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

Primary Purpose

Primary Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Pterygium focused on measuring pterygium, gatifloxacin, moxifloxacin, corneal epithelial defect

Eligibility Criteria

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

Inclusion Criteria:

  1. diagnosis of primary pterygium with a clinical indication for surgery
  2. informed consent

Exclusion Criteria:

  1. known allergic reaction to fluoroquinolones.
  2. secondary\recurrent pterygium or clinical suspected conjunctival tumor.
  3. eye surgery in the last 6 months.
  4. eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn.
  5. low compliance.
  6. pregnancy

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Moxifloxacin

Gatifloxacin

Arm Description

About 20 patients treated by Moxifloxacin ophthalmic solution 0.5% (Vigamox) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.

About 20 patients treated by Gatifloxacin ophthalmic solution 0.3% (Zymar) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.

Outcomes

Primary Outcome Measures

rate of corneal epithelial defect closure

Secondary Outcome Measures

toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction

Full Information

First Posted
May 4, 2009
Last Updated
May 4, 2009
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00892918
Brief Title
Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision
Official Title
A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether there is a difference in corneal epithelial healing rate and/or toxicity following pterygium excision, between eyes treated post-operatively by moxifloxacin(VIGAMOX)versus gatifloxacin (ZYMAR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Pterygium
Keywords
pterygium, gatifloxacin, moxifloxacin, corneal epithelial defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
About 20 patients treated by Moxifloxacin ophthalmic solution 0.5% (Vigamox) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.
Arm Title
Gatifloxacin
Arm Type
Active Comparator
Arm Description
About 20 patients treated by Gatifloxacin ophthalmic solution 0.3% (Zymar) 4 times a day (one drop each time) after pterygium excision with Mitomycin C application.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%
Intervention Description
Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.
Primary Outcome Measure Information:
Title
rate of corneal epithelial defect closure
Time Frame
21 days
Secondary Outcome Measure Information:
Title
toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction
Time Frame
12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of primary pterygium with a clinical indication for surgery informed consent Exclusion Criteria: known allergic reaction to fluoroquinolones. secondary\recurrent pterygium or clinical suspected conjunctival tumor. eye surgery in the last 6 months. eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn. low compliance. pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fani Segev, MD
Phone
972-52-6995044
Email
fsegev@netvision.net.il
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Rosen, MD
Phone
972-4-6216210
Email
ermd14@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fani Segev, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fani Segev, MD
Phone
972-52-6995044
Email
fsegev@netvision.net.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
1893771
Citation
Cutarelli PE, Lass JH, Lazarus HM, Putman SC, Jacobs MR. Topical fluoroquinolones: antimicrobial activity and in vitro corneal epithelial toxicity. Curr Eye Res. 1991 Jun;10(6):557-63. doi: 10.3109/02713689109001764.
Results Reference
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PubMed Identifier
15260356
Citation
Kovoor TA, Kim AS, McCulley JP, Cavanagh HD, Jester JV, Bugde AC, Petroll WM. Evaluation of the corneal effects of topical ophthalmic fluoroquinolones using in vivo confocal microscopy. Eye Contact Lens. 2004 Apr;30(2):90-4. doi: 10.1097/01.icl.00000117255.97190.98.
Results Reference
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PubMed Identifier
14529574
Citation
Reviglio VE, Hakim MA, Song JK, O'Brien TP. Effect of topical fluoroquinolones on the expression of matrix metalloproteinases in the cornea. BMC Ophthalmol. 2003 Oct 6;3:10. doi: 10.1186/1471-2415-3-10.
Results Reference
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PubMed Identifier
10831898
Citation
Patel GM, Chuang AZ, Kiang E, Ramesh N, Mitra S, Yee RW. Epithelial healing rates with topical ciprofloxacin, ofloxacin, and ofloxacin with artificial tears after photorefractive keratectomy. J Cataract Refract Surg. 2000 May;26(5):690-4. doi: 10.1016/s0886-3350(00)00411-9.
Results Reference
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PubMed Identifier
9292666
Citation
Moreira LB, Lee RF, de Oliveira C, LaBree L, McDonnell PJ. Effect of topical fluoroquinolones on corneal re-epithelialization after excimer laser keratectomy. J Cataract Refract Surg. 1997 Jul-Aug;23(6):845-8. doi: 10.1016/s0886-3350(97)80241-6.
Results Reference
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PubMed Identifier
15953577
Citation
Burka JM, Bower KS, Vanroekel RC, Stutzman RD, Kuzmowych CP, Howard RS. The effect of fourth-generation fluoroquinolones gatifloxacin and moxifloxacin on epithelial healing following photorefractive keratectomy. Am J Ophthalmol. 2005 Jul;140(1):83-7. doi: 10.1016/j.ajo.2005.02.037.
Results Reference
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PubMed Identifier
16160500
Citation
Moshirfar M, Marx DP, Kumar R. The effect of the fourth-generation fluoroquinolones on corneal reepithelialization after penetrating keratoplasty. Cornea. 2005 Oct;24(7):833-6. doi: 10.1097/01.ico.0000157420.11448.d4.
Results Reference
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PubMed Identifier
15604869
Citation
Herrygers LA, Noecker RJ, Lane LC, Levine JM. Comparison of corneal surface effects of gatifloxacin and moxifloxacin using intensive and prolonged dosing protocols. Cornea. 2005 Jan;24(1):66-71. doi: 10.1097/01.ico.0000134182.09569.e1.
Results Reference
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PubMed Identifier
17525660
Citation
Barequet IS, Habot-Wilner Z, Lavinsky F, Ziv H, Belkin M, Rosner M. Effect of fourth-generation fluoroquinolones on the healing rate of corneal erosions in an animal model. Cornea. 2007 Jun;26(5):606-9. doi: 10.1097/ICO.0b013e318041f08e.
Results Reference
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Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

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