Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT01298700
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 806
- Ocular hypertension or glaucoma in each eye
- Requires intraocular pressure (IOP)-lowering therapy in both eyes
- Best corrected visual acuity of 20/100 or better in each eye
- Ocular seasonal allergies within 2 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimatoprost 0.01% Ophthalmic Solution 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 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events 24 Months An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia" 24 Months An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.
Trial Locations
- Locations (50)
Glaucoma Service The Rabin Medical Center
๐ฎ๐ฑPetach Tiqva, Israel
Kaplan Medical Center
๐ฎ๐ฑRehovot, Israel
UZ Leuven
๐ง๐ชLeuven, Belgium
CHU Sart Tilman
๐ง๐ชLiege, Belgium
Josa Andras Oktatokorhaz
๐ญ๐บNyรญregyhรกza, Hungary
Carmel Medical Center
๐ฎ๐ฑHaifa, Israel
Tel Aviv Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Sheba Medical Center
๐ฎ๐ฑTel-Hashomer, Israel
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
๐ต๐ฑPoznan, Poland
Centre Hospitalier Universitaire de Bordeaux
๐ซ๐ทBordeaux, France
Augenzentrum Siegburg
๐ฉ๐ชSiegburg, Germany
Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
๐ฎ๐นRome, Italy
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
๐ต๐ฑSzczecin, Poland
Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
๐ต๐ฑWarszawa, Poland
Birmingham & Midland Eye Center
๐ฌ๐งBirmingham, United Kingdom
Hospital Universitario Miguel Servet
๐ช๐ธZaragoza, Spain
University of Szeged Szent-Gyorgyi Albert Clinical Center
๐ญ๐บSzeged, Hungary
Azienda Ospedaliera Universitaria
๐ฎ๐นCatania, Italy
University Hospital Brno
๐จ๐ฟBrno, Czechia
Istituto Scientifico San Raffaele
๐ฎ๐นMilano, Italy
Budapest Retina Associates Kft.
๐ญ๐บBudapest, Hungary
University Hospital Nottingham
๐ฌ๐งNottingham, United Kingdom
Department of Ophthalmology, University of Tuebingen
๐ฉ๐ชTubingen, Germany
Hospital Universitario La Paz
๐ช๐ธMadrid, Spain
Instituto oftalmologico Fernandez Vega
๐ช๐ธOviedo, Spain
Azlenda Ospedaliero Universitaria Careggi Viale
๐ฎ๐นFirenze, Italy
Clinique Montcelli
๐ซ๐ทMarseille, France
Johannes Gutenberg Univ Mainz
๐ฉ๐ชMainz, Germany
Thelen Private Practice
๐ฉ๐ชMลฑnster, Germany
Eye Clinic
๐จ๐ฟFrydstejn, Czechia
Universitat Augenklinik
๐ฉ๐ชFreiburg, Germany
University Med. School of Debrecen
๐ญ๐บDebrecen, Hungary
Univ. des Saarlandes
๐ฉ๐ชHomburg Saar, Germany
Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
๐ฎ๐นParma, Italy
Samodzielny Publiczny Szpital
๐ต๐ฑSzczecin, Poland
EuroMedic Kliniki Specjalistyczne
๐ต๐ฑKatowice, Poland
Samodzielny Szpital Kliniczny
๐ต๐ฑWarszawa, Poland
Instituro Condal de Oftalmologia
๐ช๐ธBarcelona, Spain
Huntingdon Glaucoma Diagnostic & Research Centre
๐ฌ๐งHuntingdon, United Kingdom
Hospital Quiron Barcelona
๐ช๐ธBarcelona, Spain
Centro de Ojos de La Coruรฑa
๐ช๐ธA Coruรฑa, Spain
ZOZ OKO- TEST Poradnia Okulistyczna
๐ต๐ฑNowy Targ, Poland
Norfolk and Norwich Hospital
๐ฌ๐งNorwich, United Kingdom
Southampton General Hospital
๐ฌ๐งSouthampton, United Kingdom
Hospital de Torrevieja
๐ช๐ธAlicante, Spain
Hospital Ramon y Cajal
๐ช๐ธMadrid, Spain
Fundacion Oftalmologica Del Mediterraneo
๐ช๐ธValencia, Spain
Valles Oftalmologia Recerca
๐ช๐ธBarcelona, Spain
Western Eye Hospital
๐ฌ๐งLondon, United Kingdom
St Thomas' Hospital
๐ฌ๐งLondon, United Kingdom