GlaucomaPhase 4NCT01298700
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A Phase 4 study testing bimatoprost 0.01% ophthalmic solution and bimatoprost 0.03% ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 50 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- bimatoprost 0.01% ophthalmic solution and bimatoprost 0.03% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 31 May 2011to 6 Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Spain10 sites
Centro de Ojos de La Coruña
A Coruña, 15006
Hospital de Torrevieja
Alicante, 03018
Instituro Condal de Oftalmologia
Barcelona, 08006
Hospital Quiron Barcelona
Barcelona, 08023
Valles Oftalmologia Recerca
Barcelona, 08195
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Instituto oftalmologico Fernandez Vega
Oviedo, 33012
Fundacion Oftalmologica Del Mediterraneo
Valencia, 46015
Hospital Universitario Miguel Servet
Zaragoza, 50009
Poland7 sites
EuroMedic Kliniki Specjalistyczne
Katowice, 40-519
ZOZ OKO- TEST Poradnia Okulistyczna
Nowy Targ, 34-400
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu
Poznan, 61-848
Samodzielny Publiczny Szpital
Szczecin, 70-111
Osrodek Badan Klinicznych Euromedis Sp. z o.o.
Szczecin, 70-215
Samodzielny Szpital Kliniczny
Warsaw, 00-416
Akad. Med. w Warszawie - Ketedra I Klin. Okulistki Wyzialu L
Warsaw, 03-709
United Kingdom7 sites
Birmingham & Midland Eye Center
Birmingham, B18 7QH
Huntingdon Glaucoma Diagnostic & Research Centre
Huntingdon, PE29 6NT
Western Eye Hospital
London, NW1 5YE
St Thomas' Hospital
London, SE1 7EH
Norfolk and Norwich Hospital
Norwich, NR1 3SR
University Hospital Nottingham
Nottingham, NG7 2UH
Southampton General Hospital
Southampton, S016 6YD
Germany6 sites
Universitat Augenklinik
Freiburg im Breisgau, 79106
Univ. des Saarlandes
Homburg Saar, 66421
Johannes Gutenberg Univ Mainz
Mainz, 55131
Thelen Private Practice
Műnster, 48143
Augenzentrum Siegburg
Siegburg, 53721
Department of Ophthalmology, University of Tuebingen
Tübingen, 72076
Israel5 sites
Carmel Medical Center
Haifa, 34362
Glaucoma Service The Rabin Medical Center
Petach Tiqva, 49100
Kaplan Medical Center
Rehovot, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer, 52621
Italy5 sites
Azienda Ospedaliera Universitaria
Catania, 95123
Azlenda Ospedaliero Universitaria Careggi Viale
Florence, 50134
Istituto Scientifico San Raffaele
Milan, 20132
Dipartimento di Scienze Otorino-Odonto-Oftalmologiche e Cerv
Parma, 43126
Fondazione G.B. Bietti per l'Oftalmologia I.R.C.C.S.
Rome, 00198
Hungary4 sites
Budapest Retina Associates Kft.
Budapest, H-1133
University Med. School of Debrecen
Debrecen, H-4032
Josa Andras Oktatokorhaz
Nyíregyháza, H-4400
University of Szeged Szent-Gyorgyi Albert Clinical Center
Szeged, H-6720
Czechia2 sites
University Hospital Brno
Brno, 62500
Eye Clinic
Frýdštejn, 463 42
France2 sites
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
Clinique Montcelli
Marseille, 13008
About this study
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
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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- bimatoprost 0.01% ophthalmic solution, bimatoprost 0.03% ophthalmic solution
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 0.01% ophthalmic solutionDrug
Also called LUMIGAN® 0.01%, LUMIGAN 0.1 mg/ml
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
bimatoprost 0.03% ophthalmic solutionDrug
Also called LUMIGAN® 0.03%, LUMIGAN 0.3 mg/ml
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. Receives: Drug: bimatoprost 0.01% ophthalmic solution |
| Bimatoprost 0.03% Ophthalmic Solution | Active comparator | One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. Receives: Drug: bimatoprost 0.03% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (1)
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study start31 May 2011
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristopher Hansen, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298700
- Sponsor's protocol ID
- 192024-054
- Other IDs
- 2010-023917-68
- Status last verified
- Dec 2017
- First submitted
- 16 Feb 2011
- Last updated
- 17 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01298700
- Acronym / sponsor ID
- 192024-054
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 31 May 2011 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 17 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | Experimental | Drug: bimatoprost 0.01% ophthalmic solutionOne drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. |
| Bimatoprost 0.03% Ophthalmic Solution | Active comparator | Drug: bimatoprost 0.03% ophthalmic solutionOne drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimatoprost 0.01% ophthalmic solutionAlso: LUMIGAN® 0.01%, LUMIGAN 0.1 mg/mlOne 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 |
| bimatoprost 0.03% ophthalmic solutionAlso: LUMIGAN® 0.03%, LUMIGAN 0.3 mg/mlOne 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 |
Primary outcome
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.
1 secondary outcome
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristopher Hansen study director
Allergan
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bimatoprost 0.01% ophthalmic solution and bimatoprost 0.03% ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 50 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Spain, Poland, United Kingdom, Germany, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.