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

January 2, 2018 updated by: Allergan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

806

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liege, Belgium, 4000
        • Chu Sart Tilman
  • Czechia
      • Brno, Czechia, 62500
        • University Hospital Brno
      • Frydstejn, Czechia, 463 42
        • Eye Clinic
  • France
      • Bordeaux, France, 33076
        • Centre Hospitalier Universitaire De Bordeaux
      • Marseille, France, 13008
        • Clinique Montcelli
  • Germany
      • Freiburg, Germany, 79106
        • Universitat Augenklinik
      • Homburg Saar, Germany, 66421
        • Univ. des Saarlandes
      • Mainz, Germany, 55131
        • Johannes Gutenberg Univ Mainz
      • Műnster, Germany, 48143
        • Thelen Private Practice
      • Siegburg, Germany, 53721
        • Augenzentrum Siegburg
      • Tubingen, Germany, 72076
        • Department of Ophthalmology, University of Tuebingen
  • Hungary
      • Budapest, Hungary, H-1133
        • Budapest Retina Associates Kft.
      • Debrecen, Hungary, H-4032
        • University Med. School of Debrecen
      • Nyíregyháza, Hungary, H-4400
        • Jósa András Oktatókórház
      • Szeged, Hungary, H-6720
        • University of Szeged Szent-Györgyi Albert Clinical Center
  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Petach Tiqva, Israel, 49100
        • Glaucoma Service The Rabin Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel-Hashomer, Israel, 52621
        • Sheba Medical Center
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliera Universitaria
      • Firenze, Italy, 50134
        • Azlenda Ospedaliero Universitaria Careggi Viale
      • Milano, Italy, 20132
        • Istituto Scientifico San Raffaele
      • Parma, Italy, 43126
        • Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
      • Rome, Italy, 00198
        • Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
  • Poland
      • Katowice, Poland, 40-519
        • EuroMedic Kliniki Specjalistyczne
      • Nowy Targ, Poland, 34-400
        • ZOZ OKO- TEST Poradnia Okulistyczna
      • Poznan, Poland, 61-848
        • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
      • Szczecin, Poland, 70-111
        • Samodzielny Publiczny Szpital
      • Szczecin, Poland, 70-215
        • Osrodek Badan Klinicznych Euromedis Sp. z o.o.
      • Warszawa, Poland, 00-416
        • Samodzielny Szpital Kliniczny
      • Warszawa, Poland, 03-709
        • Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
  • Spain
      • A Coruña, Spain, 15006
        • Centro de Ojos de La Coruña
      • Alicante, Spain, 03018
        • Hospital de Torrevieja
      • Barcelona, Spain, 08023
        • Hospital Quiron Barcelona
      • Barcelona, Spain, 08006
        • Instituro Condal de Oftalmologia
      • Barcelona, Spain, 08195
        • Valles Oftalmologia Recerca
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Oviedo, Spain, 33012
        • Instituto Oftalmologico Fernandez Vega
      • Valencia, Spain, 46015
        • Fundación Oftalmológica del Mediterráneo
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Birmingham & Midland Eye Center
      • Huntingdon, United Kingdom, PE29 6NT
        • Huntingdon Glaucoma Diagnostic & Research Centre
      • London, United Kingdom, NW1 5YE
        • Western Eye Hospital
      • London, United Kingdom, SE1 7EH
        • St Thomas' Hospital
      • Norwich, United Kingdom, NR1 3SR
        • Norfolk and Norwich Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • University Hospital Nottingham
      • Southampton, United Kingdom, S016 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • LUMIGAN® 0.01%
  • LUMIGAN 0.1 mg/ml
Active Comparator: 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.
Drug: 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.
Other Names:
  • LUMIGAN® 0.03%
  • LUMIGAN 0.3 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
Time Frame: 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.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
Time Frame: 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.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Kristopher Hansen, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2011

Primary Completion (Actual)

December 6, 2016

Study Completion (Actual)

December 6, 2016

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192024-054
  • 2010-023917-68 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ocular Hypertension

Clinical Trials on bimatoprost 0.01% ophthalmic solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe