Download PDF

Clinical Trial Results:
A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)

Summary
EudraCT number	2014-005273-37
Trial protocol	FI DE IT
Global end of trial date	25 May 2016

Results information
Results version number	v1(current)
This version publication date	21 Mar 2019
First version publication date	21 Mar 2019
Other versions
Summary report(s)	Ganfort_CSR synopsis

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

201450

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Santen Oy

Sponsor organisation address

Niittyhaankatu 20, PO BOX 33, Tampere, Finland, FIN-33721

Public contact

Global Medical Affairs, Santen Oy, 358 32848863,

Scientific contact

Global Medical Affairs, Santen Oy, 358 32848863,

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

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

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

Analysis stage

Final

Date of interim/final analysis

31 Jan 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

25 May 2016

Global end of trial reached?

Yes

Global end of trial date

25 May 2016

Was the trial ended prematurely?

Main objective of the trial

The objective of this study is to investigate whether changes in ocular signs or symptoms occur when patients with OHT or OAG (POAG or PEX) are switched from Ganfort® eye drops (FDC of bimatoprost 0.03% and timolol 0.5%) to Taptiqom® eye drops (FDC of tafluprost 0.0015% and timolol 0.5%).

Protection of trial subjects

The investigator (or designated doctor) gave each patient, prior to inclusion in the study, verbal and written information regarding the objectives and procedures of the study and the possible risks involved. The patientswere informed about their right to withdraw from the study at any time without the need to give a reason. The investigator (or designated doctor) obtained the written informed consent from all patients before any study related procedures were undertaken. The patient and the investigator (or designated doctor who gave the information) signed the informed consent form (ICF). The patients were timely informed of any new information that could have affected their willingness to continue in the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

23 Jun 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 13

Country: Number of subjects enrolled

Finland: 10

Country: Number of subjects enrolled

Germany: 73

Country: Number of subjects enrolled

Italy: 27

Worldwide total number of subjects

123

EEA total number of subjects

123

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This was an open-label, multinational, multicenter, phase IV study planned to enroll 120 patients diagnosed with ocular hypertension or open-angle glaucoma (OAG). OAG included patients with primary open-angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEX).

Screening details

Patients who had been regular users of Ganfort® for at least 4 weeks prior to screening were eligible to enter the study. Ganfort® had to be taken once-daily in the evening. At the Screening/Baseline visit PF or BAK-preserved Ganfort® was switched to PF Taptiqom®.

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Taptiqom

Arm description

Arm type

Experimental

Investigational medicinal product name

Tafluprost and timolol

Investigational medicinal product code

Other name

Taptiqom

Pharmaceutical forms

Eye drops

Routes of administration

Ocular use

Dosage and administration details

One drop of the study medication was administered once daily at 21:00 in the affected eye(s). The drops were administered in the temporal lower conjunctival cul de sac of the eye(s). Every effort was made to administer the study drops at the given time, but if extremely necessary, a deviation of one hour was allowed in the timing of administration.

Number of subjects in period 1	Taptiqom
Started	123
Completed	114
Not completed	9
Consent withdrawn by subject	4
Adverse event, non-fatal	5

Baseline characteristics

Top of page

Reporting group title

overall trial

Reporting group description

Reporting group values	overall trial	Total
Number of subjects	123	123
Age categorical
Units: Subjects
Adults (18-64 years)	47	47
From 65-84 years	75	75
85 years and over	1	1
Age continuous
Units: years
arithmetic mean (standard deviation)	66.49 ± 10.26	-
Gender categorical
Units: Subjects
Female	68	68
Male	55	55

Subject analysis set title

Safety dataset

Subject analysis set type

Safety analysis

Subject analysis set description

The safety dataset included all enrolled patients who had received at least one dose of study treatment and had a subsequent safety measurement.

Subject analysis set title

ITT dataset

Subject analysis set type

Intention-to-treat

Subject analysis set description

The ITT dataset included all enrolled patients who had received at least one dose of study treatment and had at least one post-baseline outcome measurement available (ocular symptom or ocular sign).

Subject analysis set title

12-week ITT dataset

Subject analysis set type

Intention-to-treat

Subject analysis set description

the patients continued the study up to 12 weeks

Subject analysis sets values	Safety dataset	ITT dataset	12-week ITT dataset
Number of subjects	123	121	114
Age categorical
Units: Subjects
Adults (18-64 years)	47	47	46
From 65-84 years	75	73	68
85 years and over	1	1	0
Age continuous
Units: years
arithmetic mean (standard deviation)	66.49 ± 10.26	66.47 ± 10.34	66.14 ± 10.27
Gender categorical
Units: Subjects
Female	68	66	65
Male	55	55	49

End points

Top of page

Reporting group title

Taptiqom

Reporting group description

Subject analysis set title

Safety dataset

Subject analysis set type

Safety analysis

Subject analysis set description

The safety dataset included all enrolled patients who had received at least one dose of study treatment and had a subsequent safety measurement.

Subject analysis set title

ITT dataset

Subject analysis set type

Intention-to-treat

Subject analysis set description

The ITT dataset included all enrolled patients who had received at least one dose of study treatment and had at least one post-baseline outcome measurement available (ocular symptom or ocular sign).

Subject analysis set title

12-week ITT dataset

Subject analysis set type

Intention-to-treat

Subject analysis set description

the patients continued the study up to 12 weeks

Primary: Worst ocular symptom

Top of page

End point title

Worst ocular symptom

End point description

End point type

Primary

End point timeframe

12-week changes from Screening/Baseline

End point values	ITT dataset	ITT dataset	12-week ITT dataset
Number of subjects analysed	121	121	114
Units: patients
None	0	0	45
Trace	0	0	22
Mild	47	47	35
Moderate	62	62	11
Severe	12	12	1

Change from screening

Comparison groups

ITT dataset v 12-week ITT dataset

Number of subjects included in analysis

235

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Primary: Conjunctival redness/hyperemia

Top of page

End point title

Conjunctival redness/hyperemia

End point description

End point type

Primary

End point timeframe

12-week changes from Screening/Baseline

End point values	ITT dataset	12-week ITT dataset
Number of subjects analysed	121	114
Units: patients
"0"	0	26
"0.5"	0	10
"1"	1	43
"1.5"	0	22
"2"	80	13
"2.5"	17	0
"3"	21	0
"3.5"	1	0
"4"	1	0

Change from screening

Comparison groups

12-week ITT dataset v ITT dataset

Number of subjects included in analysis

235

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.05

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Adverse events

Top of page

Timeframe for reporting adverse events

During the study

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

overall trial

Reporting group description

Serious adverse events	overall trial
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 123 (1.63%)
number of deaths (all causes)	0
number of deaths resulting from adverse events
Cardiac disorders
Atrial flutter
subjects affected / exposed	1 / 123 (0.81%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Atrioventricular block second degree
subjects affected / exposed	1 / 123 (0.81%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Arterial occlusive disease
subjects affected / exposed	1 / 123 (0.81%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	overall trial
Total subjects affected by non serious adverse events
subjects affected / exposed	44 / 123 (35.77%)
Vascular disorders
Arterial occlusive disease
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Hypotension
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Surgical and medical procedures
Tooth extraction
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
General disorders and administration site conditions
Condition aggravated
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Pyrexia
subjects affected / exposed	3 / 123 (2.44%)
occurrences all number	3
Reproductive system and breast disorders
Breast swelling
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	3 / 123 (2.44%)
occurrences all number	3
Oropharyngeal pain
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Investigations
Intraocular pressure increased
subjects affected / exposed	3 / 123 (2.44%)
occurrences all number	3
Body temperature increased
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Ultrasound kidney
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Injury, poisoning and procedural complications
Fall
Additional description: Ocular adverse event : 1, Non-ocular adverse event : 1
subjects affected / exposed	2 / 123 (1.63%)
occurrences all number	2
Superficial injury of eye
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Ligament sprain
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Skin injury
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Dysgeusia
subjects affected / exposed	2 / 123 (1.63%)
occurrences all number	2
Headache
subjects affected / exposed	11 / 123 (8.94%)
occurrences all number	11
Somnolence
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Eye disorders
Lacrimation increased
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Eye pruritus
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Eyelid haematoma
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Ocular hyperaemia
subjects affected / exposed	2 / 123 (1.63%)
occurrences all number	2
Optic disc haemorrhage
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Visual acuity reduced
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Eyelid irritation
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Diarrhoea
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Nausea
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Urticaria
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Renal and urinary disorders
Dysuria
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Renal cyst
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 123 (1.63%)
occurrences all number	2
Back pain
subjects affected / exposed	2 / 123 (1.63%)
occurrences all number	2
Myalgia
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Infections and infestations
Eye infection
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Bronchitis
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Gastroenteritis
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Influenza
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Nasopharyngitis
subjects affected / exposed	4 / 123 (3.25%)
occurrences all number	4
Periodontitis
subjects affected / exposed	1 / 123 (0.81%)
occurrences all number	1
Rhinitis
subjects affected / exposed	3 / 123 (2.44%)
occurrences all number	3

More information

Top of page

Were there any global substantial amendments to the protocol? No

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Worst ocular symptom

Primary: Worst ocular symptom

Primary: Conjunctival redness/hyperemia

Primary: Conjunctival redness/hyperemia

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Worst ocular symptom

Primary: Worst ocular symptom

Primary: Conjunctival redness/hyperemia

Primary: Conjunctival redness/hyperemia

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A phase IV study on the changes in ocular signs and symptoms in patients with ocular hypertension or open-angle glaucoma switched from Ganfort® eye drops (bimatoprost 0.03%/timolol 0.5%) to Taptiqom® eye drops (tafluprost 0.0015%/timolol 0.5%)