Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 8:02 AM
Study NCT ID:
NCT01337557
Status:
UNKNOWN
Last Update Posted:
2011-04-19
First Post:
2011-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108476', 'term': 'bepotastine'}, {'id': 'C511534', 'term': 'bepotastine besilate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire', 'timeFrame': '8 weeks', 'description': 'Contact lens comfort and wearing times (measured in hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic conjunctivitis'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of allergic conjunctivitis\n* History of contact lens intolerance\n* Between the ages of 18 and over inclusive.\n* Males or females\n* Patient is in generally good \\& stable overall health.\n* Patient likely to comply with study guidelines \\& study visits. Informed consent signed.\n* Are willing/able to return for all required study visits.\n* Are willing/able to follow instructions from the study investigator and his/her staff.\n* If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n* Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.\n\nExclusion Criteria:\n\n* Corneal refractive surgery within 6 months of this study.\n* Current use of Restasis\n* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.\n* Pregnant or lactating women.\n* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.\n* Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days;\n* Nasal or inhaled or ocular corticosteroids 14 days;\n* Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days;\n* Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days;\n* Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days;\n* Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days;\n* Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days;\n* OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days;\n* Other anticholinergic agents 3 days\n* Immunotherapy injection 1 day.'}, 'identificationModule': {'nctId': 'NCT01337557', 'briefTitle': 'Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses', 'organization': {'class': 'INDIV', 'fullName': 'Hom, Milton M., OD, FAAO'}, 'officialTitle': 'Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses', 'orgStudyIdInfo': {'id': 'MAC-03-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bepotastine', 'interventionNames': ['Drug: Bepotastine']}], 'interventions': [{'name': 'Bepotastine', 'type': 'DRUG', 'otherNames': ['Bepreve'], 'description': '1.5% bid', 'armGroupLabels': ['Bepotastine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Milton M Hom, OD FAAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hom, Milton M., OD, FAAO', 'class': 'INDIV'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Milton M. Hom, OD, FAAO.', 'oldOrganization': 'Private Practice'}}}}