Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

Primary Pterygium Clinical Trial

Official title:

A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00892918
• Other study ID #: PVZ-001
• Status: Not yet recruiting
• Phase: N/A
• First received: May 4, 2009
• Last updated: May 4, 2009
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: March 2009
• Source: Meir Medical Center
• Contact: Fani Segev, MD
• Phone: 972-52-6995044
• Email: fsegev[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Pterygium
• Pterygium

Intervention

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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of corneal epithelial defect closure		21 days	No
Secondary	toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction		12 days	Yes