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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
806

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Coruna
      • Alicante, Spain, 03018
        • Hospital de Torrevieja
      • Barcelona, Spain, 08023
        • Hospital Quirón 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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