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Clinical Trials/NCT00892918
NCT00892918
Unknown
Not Applicable

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

Meir Medical Center1 site in 1 country40 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%
Conditions
Primary Pterygium
Sponsor
Meir Medical Center
Enrollment
40
Locations
1
Primary Endpoint
rate of corneal epithelial defect closure
Last Updated
17 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
June 2010
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Arms & Interventions

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.

Intervention: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

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.

Intervention: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Outcomes

Primary Outcomes

rate of corneal epithelial defect closure

Time Frame: 21 days

Secondary Outcomes

  • toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction(12 days)

Study Sites (1)

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