[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100137567":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":11,"locations":32,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":11,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Innovative Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BLINK™ tears","EXPERIMENTAL",null,[13],"Drug: Blink® Tears Lubricant Eye Drops",{"label":15,"type":16,"description":11,"interventionNames":17},"No topical artificial tear","NO_INTERVENTION",[18],"Drug: No topical artificial tear",[20,24],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","40 patients randomized to not using a topical artificial tear.",[15],{"type":21,"name":25,"description":25,"armGroupLabels":26,"otherNames":11},"Blink® Tears Lubricant Eye Drops",[9],[28],{"name":29,"affiliation":30,"role":31},"Marc Bloomenstein, M.D.","Schwartz Laser Eye Center","PRINCIPAL_INVESTIGATOR",[33],{"facility":30,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"Scottsdale","Arizona","85260","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-111.89903,33.50921,{"lat":43,"lon":42},{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100137567","phase-4-a-clinical-evaluation-pilot-study-of-the-efficacy-of-blink-tears-lubricant-eye-drops-for-the-relief-of-dry-eye-symptoms-following-implantation-of-tecnis-multifocal-introcular-lens-100137567",false,"NCT01061268","A Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens","A Randomized Clinical Evaluation Pilot Study of the Efficacy of Blink® Tears Lubricant Eye Drops for the Relief of Dry Eye Symptoms Following Implantation of Tecnis® Multifocal Introcular Lens","Inclusion Criteria:\n\n* Male or female subjects, 21 years of age or older\n* Written, informed consent and HIPPA Authorization\n* Has 20\u002F40 or better best corrected visual acuity in the surgical eye at the Day 1 post-op visit (Visit 3)\n* Has undergone cataract surgery in only one eye and has received a Tecnis multi-focal intraocular lens in the study eye.\n* Patients not currently using any artificial tears regularly, or using low viscosity tears for symptom relief (Refresh Tears, Visine Tears, Tears Naturelle, etc.)\n* Likely to complete the entire course of the study.\n\nExclusion Criteria:\n\n* Use of systemic or ocular medications that may affect vision\n* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)\n* Subjects with diabetes mellitus\n* Uncontrolled systemic or ocular disease\n* History of ocular trauma or prior ocular surgery\n* Amblyopia or strabismus\n* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)\n* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20\u002F30 or worse\n* Subjects who may be expected to require retinal laser treatment or other surgical intervention\n* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)\n* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic\u002Fscotopic conditions)\n* Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses\n* A subject whose best-corrected visual acuity is worse than 20\u002F40 in their surgical eye\n* A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study\n* A subject that required the use of any artificial tear supplements, vasoconstrictor and\u002For redness reliever ocular drops 28 days prior to or during the study period\n* A subject that required the use of cyclosporine ocular drops 3 months prior to or during the study period\n* A subject with active ocular inflammation or corneal edema beyond what is expected on Day 1 after cataract surgery in the study eye\n* A subject with a history of conjunctivitis or ocular infection in the study eye within the past 3 months, or a history of kerato-refractive surgery in the study eye within the past 6 months of entry in to the study\n* A subject that has punctual plug(s), intracanalicular plug(s) or a history of punctual cautery in the study eye","ALL","21 Years",{"count":57,"type":58},25,"ACTUAL","INTERVENTIONAL",[61],"PHASE4","To evaluate the safety and efficacy of BLINK™ tears compared with NO topical artificial tear use in improving subject's visual performance and reduce ocular symptoms of discomfort in subjects who have undergone cataract surgery implanted with a Tecnis™ diffractive multifocal intraocular lens (IOL).",[64],"Dry Eye",[66],"Relief of dry eye symptoms following implantation of TMF IOL","COMPLETED","2012-02-15",{"date":70,"type":71},"2012-02-17","ESTIMATED",{"date":73,"type":11},"2010-01",{"date":75,"type":58},"2012-02",{"name":5,"class":6},1]