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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
bimatoprost 0.01% ophthalmic solution
bimatoprost 0.03% ophthalmic solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven
  • CHU Sart Tilman
  • University Hospital Brno
  • Eye Clinic
  • Centre Hospitalier Universitaire de Bordeaux
  • Clinique Montcelli
  • Universitat Augenklinik
  • Univ. des Saarlandes
  • Johannes Gutenberg Univ Mainz
  • Thelen Private Practice
  • Augenzentrum Siegburg
  • Department of Ophthalmology, University of Tuebingen
  • Budapest Retina Associates Kft.
  • University Med. School of Debrecen
  • Josa Andras Oktatokorhaz
  • University of Szeged Szent-Gyorgyi Albert Clinical Center
  • Carmel Medical Center
  • Glaucoma Service The Rabin Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Sheba Medical Center
  • Azienda Ospedaliera Universitaria
  • Azlenda Ospedaliero Universitaria Careggi Viale
  • Istituto Scientifico San Raffaele
  • Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
  • Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
  • EuroMedic Kliniki Specjalistyczne
  • ZOZ OKO- TEST Poradnia Okulistyczna
  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
  • Samodzielny Publiczny Szpital
  • Osrodek Badan Klinicznych Euromedis Sp. z o.o.
  • Samodzielny Szpital Kliniczny
  • Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
  • Centro de Ojos de La Coruña
  • Hospital de Torrevieja
  • Instituro Condal de Oftalmologia
  • Hospital Quiron Barcelona
  • Valles Oftalmologia Recerca
  • Hospital Ramon y Cajal
  • Hospital Universitario La Paz
  • Instituto oftalmologico Fernandez Vega
  • Fundacion Oftalmologica Del Mediterraneo
  • Hospital Universitario Miguel Servet
  • Birmingham & Midland Eye Center
  • Huntingdon Glaucoma Diagnostic & Research Centre
  • Western Eye Hospital
  • St Thomas' Hospital
  • Norfolk and Norwich Hospital
  • University Hospital Nottingham
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bimatoprost 0.01% Ophthalmic Solution

Bimatoprost 0.03% Ophthalmic Solution

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2011
Last Updated
January 2, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01298700
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2011 (Actual)
Primary Completion Date
December 6, 2016 (Actual)
Study Completion Date
December 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost 0.01% Ophthalmic Solution
Arm Type
Experimental
Arm Description
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Arm Title
Bimatoprost 0.03% Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.01% ophthalmic solution
Other Intervention Name(s)
LUMIGAN® 0.01%, LUMIGAN 0.1 mg/ml
Intervention Description
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% ophthalmic solution
Other Intervention Name(s)
LUMIGAN® 0.03%, LUMIGAN 0.3 mg/ml
Intervention Description
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Primary Outcome Measure Information:
Title
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
Description
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.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
Description
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.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristopher Hansen
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Eye Clinic
City
Frydstejn
ZIP/Postal Code
463 42
Country
Czechia
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Clinique Montcelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Universitat Augenklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Univ. des Saarlandes
City
Homburg Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Johannes Gutenberg Univ Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Thelen Private Practice
City
Műnster
ZIP/Postal Code
48143
Country
Germany
Facility Name
Augenzentrum Siegburg
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Department of Ophthalmology, University of Tuebingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Budapest Retina Associates Kft.
City
Budapest
ZIP/Postal Code
H-1133
Country
Hungary
Facility Name
University Med. School of Debrecen
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Josa Andras Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
University of Szeged Szent-Gyorgyi Albert Clinical Center
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Glaucoma Service The Rabin Medical Center
City
Petach Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azlenda Ospedaliero Universitaria Careggi Viale
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Istituto Scientifico San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
City
Rome
ZIP/Postal Code
00198
Country
Italy
Facility Name
EuroMedic Kliniki Specjalistyczne
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Facility Name
ZOZ OKO- TEST Poradnia Okulistyczna
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Samodzielny Publiczny Szpital
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Samodzielny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
City
Warszawa
ZIP/Postal Code
03-709
Country
Poland
Facility Name
Centro de Ojos de La Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital de Torrevieja
City
Alicante
ZIP/Postal Code
03018
Country
Spain
Facility Name
Instituro Condal de Oftalmologia
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Quiron Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Valles Oftalmologia Recerca
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Instituto oftalmologico Fernandez Vega
City
Oviedo
ZIP/Postal Code
33012
Country
Spain
Facility Name
Fundacion Oftalmologica Del Mediterraneo
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Birmingham & Midland Eye Center
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Huntingdon Glaucoma Diagnostic & Research Centre
City
Huntingdon
ZIP/Postal Code
PE29 6NT
Country
United Kingdom
Facility Name
Western Eye Hospital
City
London
ZIP/Postal Code
NW1 5YE
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Norfolk and Norwich Hospital
City
Norwich
ZIP/Postal Code
NR1 3SR
Country
United Kingdom
Facility Name
University Hospital Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
S016 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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