Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00892918
First received: May 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

May 4, 2009
May 4, 2009
June 2009
June 2010   (final data collection date for primary outcome measure)
rate of corneal epithelial defect closure [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Not yet recruiting
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
Both
18 Years and older
No
Contact: Fani Segev, MD 972-52-6995044 fsegev@netvision.net.il
Contact: Eli Rosen, MD 972-4-6216210 ermd14@gmail.com
Israel
 
NCT00892918
PVZ-001
No
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