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Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

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ClinicalTrials.gov Identifier: NCT00892918
Recruitment Status : Unknown
Verified March 2009 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 5, 2009
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
Meir Medical Center

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% Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. rate of corneal epithelial defect closure [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892918


Contacts
Contact: Fani Segev, MD 972-52-6995044 fsegev@netvision.net.il
Contact: Eli Rosen, MD 972-4-6216210 ermd14@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Contact: Fani Segev, MD    972-52-6995044    fsegev@netvision.net.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Fani Segev, MD Meir Medical Center

Publications:

Responsible Party: Principal Investigator-Sponsor: Dr. Segev Fani, MD, Meir Medical Center, Kfar Saba, ISRAEL
ClinicalTrials.gov Identifier: NCT00892918     History of Changes
Other Study ID Numbers: PVZ-001
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: March 2009

Keywords provided by Meir Medical Center:
pterygium
gatifloxacin
moxifloxacin
corneal epithelial defect

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Moxifloxacin
Fluoroquinolones
Gatifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors