Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00892918

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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%	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Jun 1, 2010

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.

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 [21 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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