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
  Purpose

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 Intervention
Primary Pterygium
Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • rate of corneal epithelial defect closure [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014