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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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The EU Clinical Trials Register currently displays 43850 clinical trials with a EudraCT protocol, of which 7282 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
Intraocular pressure and tolerability Study of Preserved Bimatoprost 0.01% (BMD) or Tafluprost Unit Dose Preservative Free 15microgram/ml (TUDPF) (Saflutan), in patients with Ocular hypertension or glaucoma suitable for prostaglandin therapy: A Randomized, single masked, 3 month cross-over, Investigator led, European multicentre Trial, II (SPORT II)

Summary
EudraCT number	2014-004442-10
Trial protocol	BE
Global end of trial date	01 Nov 2017

Results information
Results version number	v1(current)
This version publication date	19 Feb 2021
First version publication date	19 Feb 2021
Other versions
Summary report(s)	Synopsis Study Report SPORT II

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

SPORTII

ISRCTN number

-

US NCT number

NCT02471105

WHO universal trial number (UTN)

-

Sponsor organisation name

University Hospitals of Leuven

Sponsor organisation address

Herestraat 49, Leuven, Belgium, 3000

Public contact

Ingeborg Stalmans, University Hospitals of Leuven, 0032 16332372, ingeborg.stalmans@uzleuven.be

Scientific contact

Ingeborg Stalmans, University Hospitals of Leuven, 0032 16332372, ingeborg.stalmans@uzleuven.be

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

01 Nov 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

01 Nov 2017

Global end of trial reached?

Yes

Global end of trial date

01 Nov 2017

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective is to compare the difference in mean IOP values between the 2 groups at 6 months.

Protection of trial subjects

Patients are treated in routine care. In case of any discomfort or issues interim visits were scheduled.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

28 Oct 2015

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 11

Country: Number of subjects enrolled

Belgium: 15

Country: Number of subjects enrolled

Switzerland: 6

Country: Number of subjects enrolled

Italy: 33

Country: Number of subjects enrolled

United Kingdom: 2

Worldwide total number of subjects

67

EEA total number of subjects

61

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

19

From 65 to 84 years

47

85 years and over

1

Subject disposition

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Recruitment details

The patients are recruited during their routine glaucoma check-ups. The recruitment period ranges from 1OCT2015 until 30MAR2017.

Screening details

Patients (adults) suffering from ocular hypertension or open angle glaucoma (including those with pseudoexfoliation) and who consented to participate were enrolled in this study. Patients who were on therapy at the screening visit underwent a washout period for 4 weeks (depending on therapy) before baseline visit.

Period 1 title

2 study periods of 3 months(crossover) (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Investigator ^[1]

Are arms mutually exclusive

Yes

Arm A

Arm description

Patient receives preservative-free tafluprost 15 microgram/ml in period 1 (3 months) followed by bimatoprost 0.1mg/ml with 0.02% benzalkonium chloride (BAK) in period 2 (3 months)

Arm type

Active comparator

Investigational medicinal product name

Saflutan/Lumigan

Investigational medicinal product code

Other name

Pharmaceutical forms

Eye drops

Routes of administration

Ophthalmic use

Dosage and administration details

Instill one eye drop in each eye every night at 8:30 PM.

Arm B

Arm description

Patient receives bimatoprost 0.1mg/ml with 0.02% benzalkonium chloride (BAK) followed by preservative-free tafluprost 15 microgram/ml in period 1 (3 months) in period 2 (3 months)

Arm type

Active comparator

Investigational medicinal product name

Lumigan/Saflutan

Investigational medicinal product code

Other name

Pharmaceutical forms

Eye drops

Routes of administration

Ophthalmic use

Dosage and administration details

Instill one eye drop in each eye every evening at 8:30PM

Notes
[1] - The roles blinded appear inconsistent with a simple blinded trial.
Justification: This is an investigator-masked study. The subject was not blinded because packaging was visibly different. It was technical not possible to modify the package in such way that patient would be masked.

Number of subjects in period 1	Arm A	Arm B
Started	33	34
Wash-out	33	34
Completed	33	34

Baseline characteristics

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Reporting group title

2 study periods of 3 months(crossover)

Reporting group description

all 67 patients were included in study analysis

Reporting group values	2 study periods of 3 months(crossover)	Total
Number of subjects	67	67
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	19	19
From 65-84 years	47	47
85 years and over	1	1
Gender categorical
Units: Subjects
Female	33	33
Male	34	34

End points

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Reporting group title

Arm A

Reporting group description

Patient receives preservative-free tafluprost 15 microgram/ml in period 1 (3 months) followed by bimatoprost 0.1mg/ml with 0.02% benzalkonium chloride (BAK) in period 2 (3 months)

Reporting group title

Arm B

Reporting group description

Patient receives bimatoprost 0.1mg/ml with 0.02% benzalkonium chloride (BAK) followed by preservative-free tafluprost 15 microgram/ml in period 1 (3 months) in period 2 (3 months)

Primary: Difference in mean IOP values between the 2 groups at 6 months

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End point title

Difference in mean IOP values between the 2 groups at 6 months

End point description

The primary endpoint will be the difference in mean IOP values between the 2 groups at 6 months

End point type

Primary

End point timeframe

6 months

End point values	Arm A	Arm B
Number of subjects analysed	33	31
Units: mmHg
number (not applicable)	33	31

Full analysis set

Comparison groups

Arm B v Arm A

Number of subjects included in analysis

64

Analysis specification

Pre-specified

Analysis type

P-value

< 0.05

Method

ANOVA

Parameter type

Mean difference (final values)

Confidence interval

Secondary: Difference in IOP values between the groups in change from baseline IOP at month 3 and month 6

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End point title

Difference in IOP values between the groups in change from baseline IOP at month 3 and month 6

End point description

The difference in IOP values between the groups in change from baseline IOP at month 3 and month 6 respectively;

End point type

Secondary

End point timeframe

6 months

End point values	Arm A	Arm B
Number of subjects analysed	33	31
Units: mmHg
number (not applicable)	33	31

No statistical analyses for this end point

Secondary: Difference in mean IOP between the 2 groups at 3 months

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End point title

Difference in mean IOP between the 2 groups at 3 months

End point description

The difference in mean IOP between the 2 groups at 3 months

End point type

Secondary

End point timeframe

3 months

End point values	Arm A	Arm B
Number of subjects analysed	33	31
Units: mmHg
number (not applicable)	33	31

No statistical analyses for this end point

Secondary: difference in IOP between the 2 groups at each timepoints at months 3 and 6

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End point title

difference in IOP between the 2 groups at each timepoints at months 3 and 6

End point description

The difference in IOP between the 2 groups at each timepoints at months 3 and 6;

End point type

Secondary

End point timeframe

6 months

End point values	Arm A	Arm B
Number of subjects analysed	33	31
Units: mmHg
number (not applicable)	33	31

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

28OCT2015 until 1NOV2017

Assessment type

Systematic

Dictionary name

ICD

Dictionary version

9

Reporting group title

Arm A

Reporting group description

-

Reporting group title

Arm B

Reporting group description

-

Serious adverse events	Arm A	Arm B
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 33 (9.09%)	2 / 34 (5.88%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Cardiac disorders
Myocardial infarction
Additional description: Segment elevation myocardial infarction (STEMI)
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Continuous positive airway pressure
Additional description: Start of CPAP because of sleepapnea.
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Lichen sclerosus repair
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Pancreatitis
Additional description: Mild pancreatitis
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Arm A	Arm B
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 33 (30.30%)	11 / 34 (32.35%)
General disorders and administration site conditions
Common cold
subjects affected / exposed	1 / 33 (3.03%)	1 / 34 (2.94%)
occurrences all number	1	1
Blood and lymphatic system disorders
Increased arterial hypertension
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Eye disorders
Itching feeling in both eyes
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Gritty feeling in both eyes
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Worsening of dry feeling in both eyes
subjects affected / exposed	2 / 33 (6.06%)	0 / 34 (0.00%)
occurrences all number	2	0
Darkening of skin around the eyes
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Growth of eye lashes
subjects affected / exposed	0 / 33 (0.00%)	2 / 34 (5.88%)
occurrences all number	0	2
Posterior capsular fibrosis
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Burning sensation in eyes
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Rash around eyes
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Epitheliopathy
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Blepharitis
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Conjunctival hyperaemia
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
Hernia diaphragmatic
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Bronchitis
subjects affected / exposed	1 / 33 (3.03%)	0 / 34 (0.00%)
occurrences all number	1	0
Renal and urinary disorders
Urinary tract infection
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Osteoarthritis in neck
subjects affected / exposed	0 / 33 (0.00%)	1 / 34 (2.94%)
occurrences all number	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

21 Sep 2015

Correction of typo in title: Bimatoprost 0.01% instead of 0.1% New full title: Intraocular pressure and tolerability Study of Preserved Bimatoprost 0.01% (BIMMD) or Tafluprost Unit Dose Preservative Free 15microgram/ml (TUDPF) (Saflutan), in patients with Ocular hypertension or glaucoma suitable for prostaglandin therapy: A Randomized, single masked, 3 month cross-over, Investigator led, European multicentre Trial, II (SPORT II)

16 Dec 2015

Exclusion criteria "History of COPD, Asthma or heart failure" was added to the protocol. The time frame for keeping all study data and documents has been adjusted from 5 to 20 years, in accordance with Belgian legislation and European Directive 2005/28 / EC.

09 Jun 2016

A sentence has been amended in the Informed Consent Form so that this form is identical to the protocol.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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