GlaucomaPhase 4SPORTNCT01975714
Intraocular Pressure and Tolerability Study of Preservative-free Prostaglandins (Bimatoprost and Latanoprost) on Glaucoma and Ocular Hypertension: European, Multicentric, Investigator-led, Single Masked Study
A Phase 4 study testing Preservative-free latanoprost and Preservative-free bimatoprost in people with Glaucoma and Ocular Hypertension, run by Association for Innovation and Biomedical Research on Light and Image at 7 sites in 6 countries.
Trial summary
Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with… Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Preservative-free latanoprost and Preservative-free bimatoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ocular hypertension, pseudoexfoliation glaucoma (XFG) or primary open-angle glaucoma (POAG) patients that have been on a preserved prostaglandin monotherapy for at least 6 weeks. At prescreening and screening visit the IOP is less than or equal to 21 mm Hg in both eyes.
Who cannot join
- Any ocular condition that are of safety concern, visual field defects with an MD value above -12dB, a closed/barely open anterior chamber angles or history of acute angle closure on either eye, ocular surgery within the past three months on either eye; glaucoma surgery within the past 6 months on either eye, ocular inflammation/infection occurring within three months prior to pretrial visit on either eye, pigmentary glaucoma or neovascular glaucoma on either eye, topical ocular medication that can interfere with study medication on either eye and known hypersensitivity to any component of the trial drug solutions and participation in any other clinical trial, involving an investigational drug within one month prior to pretrial visit
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
Official title: Intraocular Pressure and Tolerability Study of Preservative Free Bimatoprost 0.03% Unit Dose (BUDPF) or Preservative Free Latanoprost 0.005% Unit Dose (LUDPF) (Monoprost®) in Patients With Ocular Hypertension or Glaucoma: A Randomized, Single Masked, 3 Month Cross-over, Investigator Led, European Multicentre Trial (SPORT)
Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was recently launched in a number of countries in Europe and contains latanoprost in a new preservative free formulation.
It is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. A better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.
Read more
The hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmHg.
(AIBILI applied for an unrestricted grant from Allergan to perform this study)
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Preservative-free latanoprost, Preservative-free bimatoprost
- Keywords
- Glaucoma, Ocular hypertension, Preservative-free prostaglandins
- 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.
Preservative-free latanoprostDrug
Also called Monoprost
Preservative-free bimatoprostDrug
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost (Period I) + Bimatoprost (Period II) | Experimental | Preservative-free latanoprost 0.005% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months.
After the follow-up visit, patient will start Preservative-free bimatoprost 0.03% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months. Receives: Drug: Preservative-free latanoprost; Drug: Preservative-free bimatoprost |
| Bimatoprost (Period I) and Latanoprost (Period II) | Experimental | Preservative-free bimatoprost 0.03% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months.
After the follow-up visit, patient will start Preservative-free latanoprost 0.005% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months. Receives: Drug: Preservative-free latanoprost; Drug: Preservative-free bimatoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean IOP values between the 2 groups at 6 months
Measured: 6 months
Secondary outcomes (1)
Difference in IOP values IOP values, visual acuity, hyperaemia, visual acuity and tolerability between the groups in change from baseline
Measured: Month 3; Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975714
- Sponsor's protocol ID
- ECR-GLC-2013-06
- Acronym
- SPORT
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2013
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure and Tolerability Study of Preservative Free Bimatoprost 0.03% Unit Dose (BUDPF) or Preservative Free Latanoprost 0.005% Unit Dose (LUDPF) (Monoprost®) in Patients With Ocular Hypertension or Glaucoma: A Randomized, Single Masked, 3 Month Cross-over, Investigator Led, European Multicentre Trial (SPORT)
- ClinicalTrials.gov ID
- NCT01975714
- Acronym / sponsor ID
- SPORT / ECR-GLC-2013-06
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular hypertension, Preservative-free prostaglandins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was recently launched in a number of countries in Europe and contains latanoprost in a new preservative free formulation.
It is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. A better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy.
The hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmHg.
(AIBILI applied for an unrestricted grant from Allergan to perform this study)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprost (Period I) + Bimatoprost (Period II) | Experimental | Drug: Preservative-free latanoprost, Drug: Preservative-free bimatoprostPreservative-free latanoprost 0.005% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months. After the follow-up visit, patient will start Preservative-free bimatoprost 0.03% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months. |
| Bimatoprost (Period I) and Latanoprost (Period II) | Experimental | Drug: Preservative-free latanoprost, Drug: Preservative-free bimatoprostPreservative-free bimatoprost 0.03% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months. After the follow-up visit, patient will start Preservative-free latanoprost 0.005% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ocular hypertension, pseudoexfoliation glaucoma (XFG) or primary open-angle glaucoma (POAG) patients that have been on a preserved prostaglandin monotherapy for at least 6 weeks. At prescreening and screening visit the IOP is less than or equal to 21 mm Hg in both eyes.
Key exclusion criteria (1 listed)
- Any ocular condition that are of safety concern, visual field defects with an MD value above -12dB, a closed/barely open anterior chamber angles or history of acute angle closure on either eye, ocular surgery within the past three months on either eye; glaucoma surgery within the past 6 months on either eye, ocular inflammation/infection occurring within three months prior to pretrial visit on either eye, pigmentary glaucoma or neovascular glaucoma on either eye, topical ocular medication that can interfere with study medication on either eye and known hypersensitivity to any component of the trial drug solutions and participation in any other clinical trial, involving an investigational drug within one month prior to pretrial visit
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 |
|---|---|---|
| Preservative-free latanoprostAlso: Monoprost | Drug | Bimatoprost (Period I) and Latanoprost (Period II), Latanoprost (Period I) + Bimatoprost (Period II) |
| Preservative-free bimatoprost | Drug | Bimatoprost (Period I) and Latanoprost (Period II), Latanoprost (Period I) + Bimatoprost (Period II) |
Primary outcome
Difference in mean IOP values between the 2 groups at 6 months
Time frame: 6 months
1 secondary outcome
Difference in IOP values IOP values, visual acuity, hyperaemia, visual acuity and tolerability between the groups in change from baseline
Time frame: Month 3; Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
Ingeborg Stalmans, MD principal investigator
UZ Leuven
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative-free latanoprost and Preservative-free bimatoprost in people with Glaucoma and Ocular Hypertension, run by Association for Innovation and Biomedical Research on Light and Image at 7 sites in 6 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 1 inclusion and 1 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Austria, Belgium, Portugal, Switzerland and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in mean IOP values between the 2 groups at 6 months (time frame: 6 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 29 Oct 2015.