Ocular HypertensionPhase 4SPORTIINCT02471105
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
A Phase 4 study testing Preserved Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15microgram/ml in people with Ocular Hypertension and Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in 5 countries.
Trial summary
This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- Preserved Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15microgram/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Sep 2015to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes
- Patient is at least 18 years
- Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form.
Who cannot join
- Unwilling to sign informed consent;
- Younger than 18 years old;
- Ocular condition that are of safety concern and that can interfere with the study results;
- Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation
- Contact lens wearer;
- Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;
Show all 17Show fewer
- Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty 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 pre-trial visit on either eye;
- Concomitant topical ocular medication that can interfere with study medication on either eye;
- Known hypersensitivity to any component of the trial drug solutions;
- Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;
- Refractive surgery patients at any time;
- Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;
- Inability to adhere to treatment/visit plan;
- Have participated in any other Interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.
- History of COPD, asthma or heart failure
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Italy2 sites, 2 recruiting
- Not yet recruiting
San Paolo Hospital
Milan
Luca Rossetti
- Not yet recruiting
Bietti Foundation
Rome
francesco Oddone
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire
Andrew McNaught
- Not yet recruiting
Western Eye Hospital
London
Francesca Cordeiro
Austria1 site, 1 recruiting
- Recruiting
Hommer Ophthalmology Institute
Vienna
Anton Hommer
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
Ingeborg Stalmans, Phd, 003216332372, ingborg.stalmans@uzleuven.be
Sien Boons, Optometrist, 003216340391, sien.boons@uzleuven.be
Switzerland1 site, 1 recruiting
- Not yet recruiting
Clinical Research Centre Momorial A. de Rotschild
Geneva
Gordana Megevand
About this study
Official title: IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy
This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
Read the detailed description
- A prospective, randomized, investigator-masked, crossover comparison;
- Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study
- Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).
- Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit;
- Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;
- After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month
- After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening;
- After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;
- Intermediate safety visits may be scheduled at the discretion of the investigator.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- Preserved Bimatoprost 0.01%, Tafluprost Unit Dose Preservative Free 15microgram/ml
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserved Bimatoprost 0.01%Drug
Also called BIMMD, Lumigan 0.01 %
Eye drops solution Topical use Once in the evening 3 months
Tafluprost Unit Dose Preservative Free 15microgram/mlDrug
Also called TUDPF, Saflutan
Eye drops solution Topical use Once in the evening 3 months
| Study group | Role | What they receive |
|---|---|---|
| Lumigan 0.01% + Saflutan 15 µg/ml | Experimental | Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months Receives: Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml |
| Saflutan 15 µg/ml + Lumigan 0.01% | Experimental | Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months Receives: Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in mean IOP values between the 2 groups
Measured: 6 months
Secondary outcomes (3)
the difference in IOP values between the groups in change from baseline IOP
Measured: month 3 and month 6
the difference in mean IOP between the 2 groups
Measured: month 3
the difference in IOP between the 2 groups at each timepoints
Measured: month 3 and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471105
- Sponsor's protocol ID
- S57304
- Acronym
- SPORTII
- Status last verified
- May 2016
- First submitted
- 31 Mar 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print.
PubMed 33818170
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy
- ClinicalTrials.gov ID
- NCT02471105
- Acronym / sponsor ID
- SPORTII / S57304
- Conditions
- Ocular Hypertension, Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Sep 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Jun 2015 (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.
This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
Detailed description
- A prospective, randomized, investigator-masked, crossover comparison;
- Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study
- Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).
- Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit;
- Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;
- After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month
- After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening;
- After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;
- Intermediate safety visits may be scheduled at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumigan 0.01% + Saflutan 15 µg/ml | Experimental | Drug: Preserved Bimatoprost 0.01%, Drug: Tafluprost Unit Dose Preservative Free 15microgram/mlBimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months |
| Saflutan 15 µg/ml + Lumigan 0.01% | Experimental | Drug: Preserved Bimatoprost 0.01%, Drug: Tafluprost Unit Dose Preservative Free 15microgram/mlTafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes
- Patient is at least 18 years
- Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form.
Key exclusion criteria (17 listed)
- Unwilling to sign informed consent;
- Younger than 18 years old;
- Ocular condition that are of safety concern and that can interfere with the study results;
- Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation
- Contact lens wearer;
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 |
|---|---|---|
| Preserved Bimatoprost 0.01%Also: BIMMD, Lumigan 0.01 %Eye drops solution Topical use Once in the evening 3 months | Drug | Lumigan 0.01% + Saflutan 15 µg/ml, Saflutan 15 µg/ml + Lumigan 0.01% |
| Tafluprost Unit Dose Preservative Free 15microgram/mlAlso: TUDPF, SaflutanEye drops solution Topical use Once in the evening 3 months | Drug | Lumigan 0.01% + Saflutan 15 µg/ml, Saflutan 15 µg/ml + Lumigan 0.01% |
Primary outcome
the difference in mean IOP values between the 2 groups
Time frame: 6 months
3 secondary outcomes
the difference in IOP values between the groups in change from baseline IOP
Time frame: month 3 and month 6
the difference in mean IOP between the 2 groups
Time frame: month 3
the difference in IOP between the 2 groups at each timepoints
Time frame: month 3 and month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 33818170Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print.
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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, Phd principal investigator
UZ Leuven
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preserved Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15microgram/ml in people with Ocular Hypertension and Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in 5 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 17 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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, United Kingdom, Austria, Belgium, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingeborg Stalmans, Phd (003216332372, ingeborg.stalmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference in mean IOP values between the 2 groups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471105, which also lists 1 linked publication.
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 12 May 2016.