Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

NCT ID: NCT00892918

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Primary Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Intervention Type DRUG

Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.

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.

Group Type ACTIVE_COMPARATOR

Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Intervention Type DRUG

Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meir Medical Center, Kfar Saba, ISRAEL

Principal Investigators

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Fani Segev, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Fani Segev, MD

Role: CONTACT

972-52-6995044

Eli Rosen, MD

Role: CONTACT

972-4-6216210

Facility Contacts

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Fani Segev, MD

Role: primary

972-52-6995044

References

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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.

Reference Type BACKGROUND
PMID: 1893771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15260356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14529574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10831898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9292666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15953577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16160500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15604869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17525660 (View on PubMed)

Other Identifiers

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PVZ-001

Identifier Type: -

Identifier Source: org_study_id

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