Clinical trial NCT01298700: Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
timeFrame: 24 Months
Secondary outcomes:
measure: Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
timeFrame: 24 Months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Brno
country: Czechia
facility: University Hospital Brno
city: Frydstejn
country: Czechia
facility: Eye Clinic
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Marseille
country: France
facility: Clinique Montcelli
city: Freiburg
country: Germany
facility: Universitat Augenklinik
city: Homburg Saar
country: Germany
facility: Univ. des Saarlandes
city: Mainz
country: Germany
facility: Johannes Gutenberg Univ Mainz
city: Műnster
country: Germany
facility: Thelen Private Practice
city: Siegburg
country: Germany
facility: Augenzentrum Siegburg
city: Tubingen
country: Germany
facility: Department of Ophthalmology, University of Tuebingen
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: University Med. School of Debrecen
city: Nyíregyháza
country: Hungary
facility: Josa Andras Oktatokorhaz
city: Szeged
country: Hungary
facility: University of Szeged Szent-Gyorgyi Albert Clinical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Petach Tiqva
country: Israel
facility: Glaucoma Service The Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Firenze
country: Italy
facility: Azlenda Ospedaliero Universitaria Careggi Viale
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele
city: Parma
country: Italy
facility: Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
city: Rome
country: Italy
facility: Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
city: Katowice
country: Poland
facility: EuroMedic Kliniki Specjalistyczne
city: Nowy Targ
country: Poland
facility: ZOZ OKO- TEST Poradnia Okulistyczna
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital
city: Szczecin
country: Poland
facility: Osrodek Badan Klinicznych Euromedis Sp. z o.o.
city: Warszawa
country: Poland
facility: Samodzielny Szpital Kliniczny
city: Warszawa
country: Poland
facility: Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
city: A Coruña
country: Spain
facility: Centro de Ojos de La Coruña
city: Alicante
country: Spain
facility: Hospital de Torrevieja
city: Barcelona
country: Spain
facility: Instituro Condal de Oftalmologia
city: Barcelona
country: Spain
facility: Hospital Quiron Barcelona
city: Barcelona
country: Spain
facility: Valles Oftalmologia Recerca
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Instituto oftalmologico Fernandez Vega
city: Valencia
country: Spain
facility: Fundacion Oftalmologica Del Mediterraneo
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Birmingham
country: United Kingdom
facility: Birmingham & Midland Eye Center
city: Huntingdon
country: United Kingdom
facility: Huntingdon Glaucoma Diagnostic & Research Centre
city: London
country: United Kingdom
facility: Western Eye Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
city: Nottingham
country: United Kingdom
facility: University Hospital Nottingham
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Allergan
name: Kristopher Hansen
role: STUDY_DIRECTOR
References: