Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

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ClinicalTrials.gov Identifier: NCT00892918

Recruitment Status : Unknown

Verified March 2009 by Meir Medical Center.
Recruitment status was: Not yet recruiting

First Posted : May 5, 2009

Last Update Posted : May 5, 2009

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Meir Medical Center

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).

Condition or disease	Intervention/treatment	Phase
Primary Pterygium	Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.
Study Start Date :	June 2009
Estimated Primary Completion Date :	June 2010
Estimated Study Completion Date :	June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Gatifloxacin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Moxifloxacin 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.	Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3% Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.
Active Comparator: Gatifloxacin 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.	Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3% Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.

Outcome Measures

Primary Outcome Measures :

rate of corneal epithelial defect closure [ Time Frame: 21 days ]

Secondary Outcome Measures :

toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892918

Contacts

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Contact: Fani Segev, MD	972-52-6995044	fsegev@netvision.net.il
Contact: Eli Rosen, MD	972-4-6216210	ermd14@gmail.com

Locations

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Israel
Meir Medical Center
Kfar Saba, Israel, 44281
Contact: Fani Segev, MD 972-52-6995044 fsegev@netvision.net.il

Sponsors and Collaborators

Meir Medical Center

Investigators

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Principal Investigator:	Fani Segev, MD	Meir Medical Center

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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Responsible Party:	Principal Investigator-Sponsor: Dr. Segev Fani, MD, Meir Medical Center, Kfar Saba, ISRAEL
ClinicalTrials.gov Identifier:	NCT00892918
Other Study ID Numbers:	PVZ-001
First Posted:	May 5, 2009 Key Record Dates
Last Update Posted:	May 5, 2009
Last Verified:	March 2009

Keywords provided by Meir Medical Center:


pterygium gatifloxacin moxifloxacin corneal epithelial defect

Additional relevant MeSH terms:

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Pterygium Conjunctival Diseases Eye Diseases Moxifloxacin Gatifloxacin Ophthalmic Solutions Pharmaceutical Solutions	Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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