Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
NCT ID: NCT01298700
Last Updated: 2018-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
806 participants
INTERVENTIONAL
2011-05-31
2016-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimatoprost 0.01% Ophthalmic Solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.01% ophthalmic solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Bimatoprost 0.03% Ophthalmic Solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.03% ophthalmic solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Interventions
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bimatoprost 0.01% ophthalmic solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.03% ophthalmic solution
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Requires intraocular pressure (IOP)-lowering therapy in both eyes
* Best corrected visual acuity of 20/100 or better in each eye
Exclusion Criteria
* Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
* Ocular surgery or laser within 3 months
* Anticipated wearing of contact lenses during the study
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Kristopher Hansen
Role: STUDY_DIRECTOR
Allergan
Locations
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UZ Leuven
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
University Hospital Brno
Brno, , Czechia
Eye Clinic
Frýdštejn, , Czechia
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Clinique Montcelli
Marseille, , France
Universitat Augenklinik
Freiburg im Breisgau, , Germany
Univ. des Saarlandes
Homburg Saar, , Germany
Johannes Gutenberg Univ Mainz
Mainz, , Germany
Thelen Private Practice
Műnster, , Germany
Augenzentrum Siegburg
Siegburg, , Germany
Department of Ophthalmology, University of Tuebingen
Tübingen, , Germany
Budapest Retina Associates Kft.
Budapest, , Hungary
University Med. School of Debrecen
Debrecen, , Hungary
Josa Andras Oktatokorhaz
Nyíregyháza, , Hungary
University of Szeged Szent-Gyorgyi Albert Clinical Center
Szeged, , Hungary
Carmel Medical Center
Haifa, , Israel
Glaucoma Service The Rabin Medical Center
Petach Tiqva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Azienda Ospedaliera Universitaria
Catania, , Italy
Azlenda Ospedaliero Universitaria Careggi Viale
Florence, , Italy
Istituto Scientifico San Raffaele
Milan, , Italy
Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
Parma, , Italy
Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
Rome, , Italy
EuroMedic Kliniki Specjalistyczne
Katowice, , Poland
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
Poznan, , Poland
Samodzielny Publiczny Szpital
Szczecin, , Poland
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
Szczecin, , Poland
Samodzielny Szpital Kliniczny
Warsaw, , Poland
Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
Warsaw, , Poland
Centro de Ojos de La Coruña
A Coruña, , Spain
Hospital de Torrevieja
Alicante, , Spain
Instituro Condal de Oftalmologia
Barcelona, , Spain
Hospital Quiron Barcelona
Barcelona, , Spain
Valles Oftalmologia Recerca
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Instituto oftalmologico Fernandez Vega
Oviedo, , Spain
Fundacion Oftalmologica Del Mediterraneo
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Birmingham & Midland Eye Center
Birmingham, , United Kingdom
Huntingdon Glaucoma Diagnostic & Research Centre
Huntingdon, , United Kingdom
Western Eye Hospital
London, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Norfolk and Norwich Hospital
Norwich, , United Kingdom
University Hospital Nottingham
Nottingham, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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2010-023917-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
192024-054
Identifier Type: -
Identifier Source: org_study_id
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