Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298700
• Other study ID #: 192024-054
• Secondary ID: 2010-023917-68
• Status: Completed
• Phase: Phase 4
• Start date: May 31, 2011
• Est. completion date: December 6, 2016

Study information

• Verified date: December 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Belgium	CHU Sart Tilman	Liege
Czechia	University Hospital Brno	Brno
Czechia	Eye Clinic	Frydstejn
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Clinique Montcelli	Marseille
Germany	Universitat Augenklinik	Freiburg
Germany	Univ. des Saarlandes	Homburg Saar
Germany	Johannes Gutenberg Univ Mainz	Mainz
Germany	Thelen Private Practice	Munster
Germany	Augenzentrum Siegburg	Siegburg
Germany	Department of Ophthalmology, University of Tuebingen	Tubingen
Hungary	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
Israel	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-Hashomer
Italy	Azienda Ospedaliera Universitaria	Catania
Italy	Azlenda Ospedaliero Universitaria Careggi Viale	Firenze
Italy	Istituto Scientifico San Raffaele	Milano
Italy	Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv	Parma
Italy	Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.	Rome
Poland	EuroMedic Kliniki Specjalistyczne	Katowice
Poland	ZOZ OKO- TEST Poradnia Okulistyczna	Nowy Targ
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu	Poznan
Poland	Osrodek Badan Klinicznych Euromedis Sp. z o.o.	Szczecin
Poland	Samodzielny Publiczny Szpital	Szczecin
Poland	Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L	Warszawa
Poland	Samodzielny Szpital Kliniczny	Warszawa
Spain	Centro de Ojos de La Coruña	A Coruña
Spain	Hospital de Torrevieja	Alicante
Spain	Hospital Quiron Barcelona	Barcelona
Spain	Instituro Condal de Oftalmologia	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
United Kingdom	Birmingham & Midland Eye Center	Birmingham
United Kingdom	Huntingdon Glaucoma Diagnostic & Research Centre	Huntingdon
United Kingdom	St Thomas' Hospital	London
United Kingdom	Western Eye Hospital	London
United Kingdom	Norfolk and Norwich Hospital	Norwich
United Kingdom	University Hospital Nottingham	Nottingham
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"	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.	24 Months