Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension
2 other identifiers
interventional
806
10 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2011
Longer than P75 for phase_4
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedStudy Start
First participant enrolled
May 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2016
CompletedResults Posted
Study results publicly available
September 17, 2018
CompletedSeptember 17, 2018
December 1, 2017
5.5 years
February 16, 2011
January 2, 2018
January 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
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.
24 Months
Secondary Outcomes (1)
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
24 Months
Study Arms (2)
Bimatoprost 0.01% Ophthalmic Solution
EXPERIMENTALOne drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Bimatoprost 0.03% Ophthalmic Solution
ACTIVE COMPARATOROne drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Interventions
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (50)
UZ Leuven
Leuven, 3000, Belgium
CHU Sart Tilman
Liège, 4000, Belgium
University Hospital Brno
Brno, 62500, Czechia
Eye Clinic
Frýdštejn, 463 42, Czechia
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076, France
Clinique Montcelli
Marseille, 13008, France
Universitat Augenklinik
Freiburg im Breisgau, 79106, Germany
Univ. des Saarlandes
Homburg Saar, 66421, Germany
Johannes Gutenberg Univ Mainz
Mainz, 55131, Germany
Thelen Private Practice
Műnster, 48143, Germany
Augenzentrum Siegburg
Siegburg, 53721, Germany
Department of Ophthalmology, University of Tuebingen
Tübingen, 72076, Germany
Budapest Retina Associates Kft.
Budapest, H-1133, Hungary
University Med. School of Debrecen
Debrecen, H-4032, Hungary
Josa Andras Oktatokorhaz
Nyíregyháza, H-4400, Hungary
University of Szeged Szent-Gyorgyi Albert Clinical Center
Szeged, H-6720, Hungary
Carmel Medical Center
Haifa, 34362, Israel
Glaucoma Service The Rabin Medical Center
Petach Tiqva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Sheba Medical Center
Tel Litwinsky, 52621, Israel
Azienda Ospedaliera Universitaria
Catania, 95123, Italy
Azlenda Ospedaliero Universitaria Careggi Viale
Florence, 50134, Italy
Istituto Scientifico San Raffaele
Milan, 20132, Italy
Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
Parma, 43126, Italy
Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
Rome, 00198, Italy
EuroMedic Kliniki Specjalistyczne
Katowice, 40-519, Poland
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, 34-400, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
Poznan, 61-848, Poland
Samodzielny Publiczny Szpital
Szczecin, 70-111, Poland
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
Szczecin, 70-215, Poland
Samodzielny Szpital Kliniczny
Warsaw, 00-416, Poland
Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
Warsaw, 03-709, Poland
Centro de Ojos de La Coruña
A Coruña, 15006, Spain
Hospital de Torrevieja
Alicante, 03018, Spain
Instituro Condal de Oftalmologia
Barcelona, 08006, Spain
Hospital Quiron Barcelona
Barcelona, 08023, Spain
Valles Oftalmologia Recerca
Barcelona, 08195, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Instituto oftalmologico Fernandez Vega
Oviedo, 33012, Spain
Fundacion Oftalmologica Del Mediterraneo
Valencia, 46015, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Birmingham & Midland Eye Center
Birmingham, B18 7QH, United Kingdom
Huntingdon Glaucoma Diagnostic & Research Centre
Huntingdon, PE29 6NT, United Kingdom
Western Eye Hospital
London, NW1 5YE, United Kingdom
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Norfolk and Norwich Hospital
Norwich, NR1 3SR, United Kingdom
University Hospital Nottingham
Nottingham, NG7 2UH, United Kingdom
Southampton General Hospital
Southampton, S016 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Robinson, MD
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Kristopher Hansen
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 18, 2011
Study Start
May 31, 2011
Primary Completion
December 6, 2016
Study Completion
December 6, 2016
Last Updated
September 17, 2018
Results First Posted
September 17, 2018
Record last verified: 2017-12