Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision - Full Text View

Sponsor:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00892918

Purpose

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	Intervention
Primary Pterygium	Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Drug Information available for: Gatifloxacin Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

rate of corneal epithelial defect closure [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892918

Contacts

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

Locations

Israel
Meir Medical Center	Not yet recruiting
Kfar Saba, Israel, 44281
Contact: Fani Segev, MD 972-52-6995044 fsegev@netvision.net.il

Sponsors and Collaborators

Meir Medical Center

Investigators

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Principal Investigator-Sponsor: Dr. Segev Fani, MD, Meir Medical Center, Kfar Saba, ISRAEL
ClinicalTrials.gov Identifier:	NCT00892918 History of Changes
Other Study ID Numbers:	PVZ-001
Study First Received:	May 4, 2009
Last Updated:	May 4, 2009
Health Authority:	Israel: Ministry of Health

Keywords provided by Meir Medical Center:

pterygium
gatifloxacin
moxifloxacin
corneal epithelial defect

Additional relevant MeSH terms:

Pterygium
Conjunctival Diseases
Eye Diseases
Gatifloxacin
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012