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Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00892918
First Posted: May 5, 2009
Last Update Posted: May 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Meir Medical Center
May 4, 2009
May 5, 2009
May 5, 2009
June 2009
June 2010   (Final data collection date for primary outcome measure)
rate of corneal epithelial defect closure [ Time Frame: 21 days ]
Same as current
No Changes Posted
toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ]
Same as current
Not Provided
Not Provided
 
Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision
A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.
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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Primary Pterygium
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: 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: Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%
  • 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.
    Intervention: Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00892918
PVZ-001
No
Not Provided
Not Provided
Principal Investigator-Sponsor: Dr. Segev Fani, MD, Meir Medical Center, Kfar Saba, ISRAEL
Meir Medical Center
Not Provided
Principal Investigator: Fani Segev, MD Meir Medical Center
Meir Medical Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP