Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT00781092
Status:
COMPLETED
Last Update Posted:
2012-09-20
First Post:
2008-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-19', 'studyFirstSubmitDate': '2008-10-27', 'studyFirstSubmitQcDate': '2008-10-27', 'lastUpdatePostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear osmolarity', 'timeFrame': '2 week, 1 month'}], 'secondaryOutcomes': [{'measure': 'Tear Break Up Time', 'timeFrame': '2 week, 1 month post op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eyes', 'LASIK', 'Laser Vision Correction'], 'conditions': ['Dry Eye']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.durrievision.com/index.cfm/research', 'label': 'Durrie Vision Research'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.', 'detailedDescription': 'This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be a suitable candidate for FDA Approved LASIK.\n* Subjects must have a stable refraction as documented by previous clinical records.\n* Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.\n* Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.\n* Subjects must be at least 18 years of age.\n* Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.\n* Subjects must sign and be given a copy of the written Informed Consent form.\n\nExclusion Criteria:\n\n* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.\n* Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.\n* Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.\n* Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.\n* Subjects who have a history of Herpes zoster or Herpes simplex keratitis.\n* Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.\n* Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\\>25 mm Hg in either eye.\n* Subjects with macular pathology in either eye.\n* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.\n* Subjects with known sensitivity to planned study concomitant medications.\n* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.\n* Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.'}, 'identificationModule': {'nctId': 'NCT00781092', 'briefTitle': 'A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Durrie Vision'}, 'officialTitle': 'A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes', 'orgStudyIdInfo': {'id': 'SUSE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Systane Ultra', 'interventionNames': ['Other: Systane Ultra']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Bausch and Lomb Sensitive Eyes', 'interventionNames': ['Other: Bausch and Lomb Sensitive Eyes']}], 'interventions': [{'name': 'Systane Ultra', 'type': 'OTHER', 'otherNames': ['Natural Tears'], 'description': 'Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative', 'armGroupLabels': ['1']}, {'name': 'Bausch and Lomb Sensitive Eyes', 'type': 'OTHER', 'otherNames': ['Saline Solution'], 'description': 'Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel S. Durrie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durrie Vision'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Durrie Vision', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Daniel S. Durrie, MD', 'investigatorAffiliation': 'Durrie Vision'}}}}