Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00892918
Status:
UNKNOWN
Last Update Posted:
2009-05-05
First Post:
2009-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-04', 'studyFirstSubmitDate': '2009-05-04', 'studyFirstSubmitQcDate': '2009-05-04', 'lastUpdatePostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of corneal epithelial defect closure', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'toxicity findings: punctate keratitis, inferior conjunctival hyperemia, conjunctival papillary reaction', 'timeFrame': '12 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pterygium', 'gatifloxacin', 'moxifloxacin', 'corneal epithelial defect'], 'conditions': ['Primary Pterygium']}, 'referencesModule': {'references': [{'pmid': '1893771', 'type': 'BACKGROUND', 'citation': 'Cutarelli PE, Lass JH, Lazarus HM, Putman SC, Jacobs MR. Topical fluoroquinolones: antimicrobial activity and in vitro corneal epithelial toxicity. Curr Eye Res. 1991 Jun;10(6):557-63. doi: 10.3109/02713689109001764.'}, {'pmid': '15260356', 'type': 'BACKGROUND', 'citation': 'Kovoor TA, Kim AS, McCulley JP, Cavanagh HD, Jester JV, Bugde AC, Petroll WM. Evaluation of the corneal effects of topical ophthalmic fluoroquinolones using in vivo confocal microscopy. Eye Contact Lens. 2004 Apr;30(2):90-4. doi: 10.1097/01.icl.00000117255.97190.98.'}, {'pmid': '14529574', 'type': 'BACKGROUND', 'citation': "Reviglio VE, Hakim MA, Song JK, O'Brien TP. Effect of topical fluoroquinolones on the expression of matrix metalloproteinases in the cornea. BMC Ophthalmol. 2003 Oct 6;3:10. doi: 10.1186/1471-2415-3-10."}, {'pmid': '10831898', 'type': 'BACKGROUND', 'citation': 'Patel GM, Chuang AZ, Kiang E, Ramesh N, Mitra S, Yee RW. Epithelial healing rates with topical ciprofloxacin, ofloxacin, and ofloxacin with artificial tears after photorefractive keratectomy. J Cataract Refract Surg. 2000 May;26(5):690-4. doi: 10.1016/s0886-3350(00)00411-9.'}, {'pmid': '9292666', 'type': 'BACKGROUND', 'citation': 'Moreira LB, Lee RF, de Oliveira C, LaBree L, McDonnell PJ. Effect of topical fluoroquinolones on corneal re-epithelialization after excimer laser keratectomy. J Cataract Refract Surg. 1997 Jul-Aug;23(6):845-8. doi: 10.1016/s0886-3350(97)80241-6.'}, {'pmid': '15953577', 'type': 'BACKGROUND', 'citation': 'Burka JM, Bower KS, Vanroekel RC, Stutzman RD, Kuzmowych CP, Howard RS. The effect of fourth-generation fluoroquinolones gatifloxacin and moxifloxacin on epithelial healing following photorefractive keratectomy. Am J Ophthalmol. 2005 Jul;140(1):83-7. doi: 10.1016/j.ajo.2005.02.037.'}, {'pmid': '16160500', 'type': 'BACKGROUND', 'citation': 'Moshirfar M, Marx DP, Kumar R. The effect of the fourth-generation fluoroquinolones on corneal reepithelialization after penetrating keratoplasty. Cornea. 2005 Oct;24(7):833-6. doi: 10.1097/01.ico.0000157420.11448.d4.'}, {'pmid': '15604869', 'type': 'BACKGROUND', 'citation': 'Herrygers LA, Noecker RJ, Lane LC, Levine JM. Comparison of corneal surface effects of gatifloxacin and moxifloxacin using intensive and prolonged dosing protocols. Cornea. 2005 Jan;24(1):66-71. doi: 10.1097/01.ico.0000134182.09569.e1.'}, {'pmid': '17525660', 'type': 'BACKGROUND', 'citation': 'Barequet IS, Habot-Wilner Z, Lavinsky F, Ziv H, Belkin M, Rosner M. Effect of fourth-generation fluoroquinolones on the healing rate of corneal erosions in an animal model. Cornea. 2007 Jun;26(5):606-9. doi: 10.1097/ICO.0b013e318041f08e.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosis of primary pterygium with a clinical indication for surgery\n2. informed consent\n\nExclusion Criteria:\n\n1. known allergic reaction to fluoroquinolones.\n2. secondary\\\\recurrent pterygium or clinical suspected conjunctival tumor.\n3. eye surgery in the last 6 months.\n4. eye disorders: severe dry eye syndrome, ocular surface diseases, glaucoma, recurrent corneal erosions, chronic corneal diseases, after chemical burn.\n5. low compliance.\n6. pregnancy'}, 'identificationModule': {'nctId': 'NCT00892918', 'briefTitle': 'Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'A Randomized Clinical Trial Comparing the Effect of Moxifloxacin Versus Gatifloxacin Following Pterygium Excision on Corneal Epithelial Healing and Epithelial Toxicity.', 'orgStudyIdInfo': {'id': 'PVZ-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': '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.', 'interventionNames': ['Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gatifloxacin', 'description': '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.', 'interventionNames': ['Drug: Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%']}], 'interventions': [{'name': 'Moxifloxacin ophthalmic solution 0.5% ; Gatifloxacin ophthalmic solution 0.3%', 'type': 'DRUG', 'description': 'Each drug will be given 4 times a day, 1 drop each time to the operated eye, for 21 days.', 'armGroupLabels': ['Gatifloxacin', 'Moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'contacts': [{'name': 'Fani Segev, MD', 'role': 'CONTACT', 'email': 'fsegev@netvision.net.il', 'phone': '972-52-6995044'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Fani Segev, MD', 'role': 'CONTACT', 'email': 'fsegev@netvision.net.il', 'phone': '972-52-6995044'}, {'name': 'Eli Rosen, MD', 'role': 'CONTACT', 'email': 'ermd14@gmail.com', 'phone': '972-4-6216210'}], 'overallOfficials': [{'name': 'Fani Segev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Principal Investigator-Sponsor: Dr. Segev Fani, MD', 'oldOrganization': 'Meir Medical Center, Kfar Saba, ISRAEL'}}}}