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Clinical Trial Results:
A phase II, observer masked, active controlled study of SYL040012 for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (SYLTAG)

Summary
EudraCT number	2013-002947-27
Trial protocol	EE DE ES
Global end of trial date	05 Aug 2015

Results information
Results version number	v1(current)
This version publication date	01 Mar 2017
First version publication date	01 Mar 2017
Other versions

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

SYL040012_IV

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Sylentis SAU - Grupo PharmaMar

Sponsor organisation address

Parque Tecnológico de Madrid C/Santiago Grisolía nº 2, Tres Cantos, Madrid, Spain, 28760

Public contact

Head of Regulatory Affairs & QP, Sylentis S.A.U., 0034 918047667, info@sylentis.com

Scientific contact

Head of Regulatory Affairs & QP, Sylentis S.A.U., 0034 918047667, info@sylentis.com

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

20 Jan 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Aug 2015

Global end of trial reached?

Yes

Global end of trial date

05 Aug 2015

Was the trial ended prematurely?

Main objective of the trial

To determine the most effective drug concentration of SYL040012 in the reduction of the intraocular pressure (IOP) after 28 days of treatment.

Protection of trial subjects

This study was conducted in compliance with ICH-GCP Guidelines, the Declaration of Helsinki (18th World Medical Assembly, 1964) and its last revision (Fortaleza, October 2013), and local laws and regulations of the countries where the study was performed.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Oct 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 80

Country: Number of subjects enrolled

Estonia: 78

Country: Number of subjects enrolled

Germany: 17

Country: Number of subjects enrolled

United States: 100

Worldwide total number of subjects

275

EEA total number of subjects

175

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)

200

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

275 patients were screened from 28 October 2014 to 06 July 2015 in 19 centers in Spain, Germany, Estonia and the USA. 91 patients were finally not included in the study. 184 (66.9%) were randomized to 5 different groups: bamosiran 0.375%, bamosiran 0.75%, bamosiran 1.125%, bamosiran 1.5% and 0.5 Timolol solution

Screening details

Age≥18 years;Signed IC;OAG or OHT;IOP≥23 mmHg;BCVA=1.0 logMAR;Stable visual field;Central corneal thickness 480-620 μm;Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

Period 1 title

Overall period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

The study was double-masked by definition for the different doses of bamosiran; but as the timolol group was dosed with a different dosage form and regimen, in order to keep a masked assessment of the study parameters, the principal investigator defined, if necessary, a different investigational staff for the treatment handling and support and for the study assessments (masked) at each site, so also the comparisons vs timolol could be considered at least masked to the assessment

Are arms mutually exclusive

Yes

0.375% Bamosiran

Arm description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.375%

Arm type

Experimental

Investigational medicinal product name

Bamosiran

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops

Routes of administration

Ophthalmic use

Dosage and administration details

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days

0.75% Bamosiran

Arm description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.75%

Arm type

Experimental

Investigational medicinal product name

Bamosiran

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days

1.125% Bamosiran

Arm description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.125%

Arm type

Experimental

Investigational medicinal product name

Bamosiran

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days

1.5% Bamosiran

Arm description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.5%

Arm type

Experimental

Investigational medicinal product name

Bamosiran

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days

0.5% Timolol

Arm description

Timolol maleate for ocular administration (eye drops) bid in each eye over a period of 28 days at a dose of 0.5%.

Arm type

Active comparator

Investigational medicinal product name

Timolol maleate

Investigational medicinal product code

Timolol

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

Timolol maleate for ocular administration (eye drops) bid in each eye over a period of 28 days at a dose of 0.5%.

Number of subjects in period 1 ^[1]	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Started	37	40	37	33	37
Completed	36	38	35	33	36
Not completed	1	2	2	0	1
Consent withdrawn by subject	-	-	-	-	1
Red and purulent eye	-	1	-	-	-
Forbidden medication	-	-	1	-	-
IOP>35 mmHg	-	1	-	-	-
Protocol deviation	1	-	1	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 91 patients were finally not included in the study due to the following reasons: Inclusion/Exclusion criteria (86) and Withdrawal of consent (5).

Baseline characteristics

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Reporting group title

0.375% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.375%

Reporting group title

0.75% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.75%

Reporting group title

1.125% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.125%

Reporting group title

1.5% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.5%

Reporting group title

0.5% Timolol

Reporting group description

Timolol maleate for ocular administration (eye drops) bid in each eye over a period of 28 days at a dose of 0.5%.

Reporting group values	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol	Total
Number of subjects	37	40	37	33	37	184
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	60.7 ± 10.4	59.4 ± 12.9	61.5 ± 10.1	62.4 ± 11.1	60.2 ± 11.5	-
Gender categorical
Units: Subjects
Female	25	24	22	24	24	119
Male	12	16	15	9	13	65
Race
Units: Subjects
Asian	0	0	0	0	1	1
Black	4	4	2	5	3	18
White	33	36	35	28	33	165
Ethnicity
Units: Subjects
Hispanic or Latino	3	7	5	3	2	20
Non-Hispanic or Latino	34	33	32	30	35	164
Height
Units: cm
arithmetic mean (standard deviation)	166 ± 9	167 ± 10	166 ± 13	165 ± 11	167 ± 10	-
Weight
Units: Kg
arithmetic mean (standard deviation)	81.7 ± 18.7	77.8 ± 18.2	78 ± 19.6	76.5 ± 17.4	85.1 ± 19.1	-
BMI
BMI=Body mass index
Units: Kg/m2
arithmetic mean (standard deviation)	29.5 ± 6.1	28.1 ± 6.4	27.9 ± 4.6	28.2 ± 5.9	30.6 ± 7.2	-
Body temperature
Units: celsius temperature
arithmetic mean (standard deviation)	36.4 ± 0.4	36.4 ± 0.4	36.5 ± 0.4	36.4 ± 0.5	36.5 ± 0.3	-
Gonioscopy test results
Units: quadrants
arithmetic mean (standard deviation)	3.5 ± 0.5	3.7 ± 0.5	3.4 ± 0.5	3.5 ± 0.5	3.6 ± 0.5	-

End points

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Reporting group title

0.375% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.375%

Reporting group title

0.75% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 0.75%

Reporting group title

1.125% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.125%

Reporting group title

1.5% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at a dose of 1.5%

Reporting group title

0.5% Timolol

Reporting group description

Timolol maleate for ocular administration (eye drops) bid in each eye over a period of 28 days at a dose of 0.5%.

Primary: Changes in diurnal IOP after 28 days of treatment

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End point title

Changes in diurnal IOP after 28 days of treatment

End point description

End point type

Primary

End point timeframe

The absolute change in mean diurnal IOP after 28 days of treatment vs day 0. The mean diurnal IOP was assessed as the mean value of the assessments at 9h, 12h and 15h, both baseline and after 28 days of treatment comparing the four levels of concentration

End point values	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Number of subjects analysed	36	38	35	33	35
Units: mmHg
arithmetic mean (standard deviation)	-2.4 ± 2.6	-3.2 ± 2.9	-3.1 ± 2.5	-3.1 ± 3.2	-6.1 ± 2.2

Attachments

Change IOP

Differences between groups

Statistical analysis description

All groups showed a reduction in the mean IOP at the end of the study, without reaching statistical significance when concentrations of bamosiran were compared. However, the concentration of bamosiran 0.75% showed the highest reduction at Day 28, followed close by the higher concentrations.

Comparison groups

1.125% Bamosiran v 0.375% Bamosiran v 1.5% Bamosiran v 0.5% Timolol v 0.75% Bamosiran

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 1 ^[2]

Method

ANCOVA

Confidence interval

Notes
[1] - Timolol 0.5% was statistically significant different when compared to the concentrations of bamosiran after 28 days of treatment (ANCOVA;p<0.001). Timolol 0.5% vs Bamosiran 1.5% -2.967 95%CI(-4.235;-1.698) p=<0.001 Timolol 0.5% vs Bamosiran 1.125% -3.056 95%CI(-4.302;-1.810) p=<0.001 Timolol 0.5% vs Bamosiran 0.75% -2.910 95%CI(-4.134;-1.685) p=<0.001 Timolol 0.5% vs Bamosiran 0.375% -3.793 95%CI(-5.050;-2.536) p=<0.001
[2] - 1.5%-1.125%: -0.059 (-1.38;1.26) p=0.930 1.5%-0.75%: 0.065 (-1.23;1.36) p=0.921 1.5%-0.375%: -0.821 (-2.15;0.51) p=0.225 1.125%-0.75%: 0.124 (-1.15;1.40) p=0.847 1.125%-0.375%: -0.762 (-0.72;0.55) p=0.252 0.75%-0.375%: -0.886 (-2.17;0.40) p=0.17

Secondary: Changes in diurnal IOP after 14 days of treatment

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End point title

Changes in diurnal IOP after 14 days of treatment

End point description

End point type

Secondary

End point timeframe

after 14 days of treatment (D14) versus baseline, assessed as the mean value of the assessments performed at 09:00, 12:00 and 15:00, both at baseline and after 14 days

End point values	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Number of subjects analysed	36	38	35	33	35
Units: mmHg
arithmetic mean (standard deviation)	-2.4 ± 2.6	-2.9 ± 2.4	-2.5 ± 2.1	-2.4 ± 3.1	-5.8 ± 1.9

Differences between groups

Statistical analysis description

No statistically significant differences were found among the concentrations of bamosiran with respect to the mean diurnal IOP after 14 days. Although no statistically significant differences were found, the concentration of 0.75% of bamosiran seems to show the highest percentage of decrease (12%) with respect to the other concentrations.

Comparison groups

0.375% Bamosiran v 0.75% Bamosiran v 1.125% Bamosiran v 1.5% Bamosiran v 0.5% Timolol

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 1 ^[4]

Method

ANCOVA

Confidence interval

Notes
[3] - Timolol 0.5% was statistically significant different when compared to the concentrations of bamosiran both after 14 days of treatment (ANCOVA; p<0.001). Timolol 0.5% vs Bamosiran 1.5%: -3.394 95%CI(-4.557; -2.232) p=<0.001 Timolol 0.5% vs Bamosiran 1.125%: -3.363 95%CI(-4.505; -2.221) p=<0.001 Timolol 0.5% vs Bamosiran 0.75%: -2.865 95%CI(-3.987; -1.742) p=<0.001 Timolol 0.5% vs Bamosiran 0.375%: -3.513 95%CI(-4.665; -2.360) p=<0.001
[4] - 1.5%-1.125%: 0.043 (-1.17;1.26) p=0.944 1.5%-0.75%: 0.532 (-0.66;1.73) p=0.381 1.5%-0.375%: -0.122 (-1.35;1.11) p=0.845 1.125%-0.75%: 0.488 (-0.69;1.66) p=0.412 1.125%-0.375%: -0.165 (-1.37;1.04) p=0.788 0.75%-0.375%: -0.653 (-1.84;0.53) p=0.279

Secondary: GQL-15 Questionnaire at Day 29

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End point title

GQL-15 Questionnaire at Day 29

End point description

The GQL-15 is a 15-item, 4-domain tool. The instrument is based on the premise that perceived visual disability (dark adaptation, disability glare, outdoor mobility tasks and activities using peripheral vision) is significantly associated with binocular visual field loss.

End point type

Secondary

End point timeframe

Patients were asked to rate their quality of life by means of the GQL-15 questionnaire at Day 29

End point values	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Number of subjects analysed	36	38	35	33	35
Units: points
arithmetic mean (standard deviation)
GQL-15 Total Score	20 ± 8.28	20.7 ± 7.68	19.4 ± 6.34	22 ± 9.65	18.7 ± 6.21
Central and near vision - Recognizing faces	1.3 ± 0.61	1.2 ± 0.63	1.3 ± 0.63	1.4 ± 0.8	1.2 ± 0.58
Central and near vision - Reading newspapers	1.3 ± 0.78	1.3 ± 0.67	1.4 ± 0.88	1.3 ± 0.54	1.4 ± 0.84
Peripheral vision - Seeing objects	1.2 ± 0.58	1.2 ± 0.51	1.1 ± 0.43	1.2 ± 0.61	1.1 ± 0.6
Peripheral vision - Walking	1.4 ± 0.77	1.4 ± 0.72	1.4 ± 0.98	1.6 ± 0.84	1.4 ± 0.77
Peripheral vision - Tripping	1.2 ± 0.47	1.2 ± 0.43	1.1 ± 0.37	1.4 ± 0.79	1.1 ± 0.4
Peripheral vision - Judging distance	1.3 ± 0.55	1.3 ± 0.71	1.2 ± 0.38	1.4 ± 0.74	1.2 ± 0.38
Peripheral vision - steps/stairs	1.3 ± 0.68	1.4 ± 0.79	1.1 ± 0.37	1.4 ± 0.83	1.1 ± 0.43
Peripheral vision - Bumping	1.2 ± 0.52	1.2 ± 0.47	1.1 ± 0.42	1.3 ± 0.68	1.1 ± 0.24
Dark adaptation - Walking	1.3 ± 0.83	1.4 ± 0.76	1.4 ± 0.69	1.5 ± 1	1.3 ± 0.61
Dark adaptation - Seeing at night	1.4 ± 0.88	1.7 ± 0.93	1.4 ± 0.73	1.8 ± 0.93	1.5 ± 0.74
Dark adaptation - Adjusting	1.4 ± 0.8	1.5 ± 0.73	1.5 ± 0.82	1.5 ± 0.87	1.4 ± 0.94
Dark adaptation - Change dark/light	1.5 ± 0.7	1.6 ± 0.75	1.5 ± 0.7	1.8 ± 0.83	1.4 ± 0.69
Dark adaptation - Finding	1.3 ± 0.62	1.3 ± 0.69	1.1 ± 0.36	1.3 ± 0.69	1.1 ± 0.28
Outdoor mobility - Crossing the road	1.3 ± 0.81	1.2 ± 0.58	1.1 ± 0.24	1.3 ± 0.76	1.1 ± 0.24

Differences between groups

Comparison groups

0.375% Bamosiran v 0.75% Bamosiran v 1.125% Bamosiran v 1.5% Bamosiran v 0.5% Timolol

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

= 0.038 ^[6]

Method

ANCOVA

Confidence interval

Notes
[5] - No statistically significant differences between Timolol 0.5% group and all the bamosiran concentration groups in any of the domains throughout the study. However, statistically significant differences were found in favour of the bamosiran 1.5% group when compared to bamosiran 1.125% group in the peripheral vision score.
[6] - bamosiran 1.5% group compared to bamosiran 1.125% group

Adverse events

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Timeframe for reporting adverse events

Overall period

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

0.375% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at doses of 0.375%

Reporting group title

0.75% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at doses of 0.75%

Reporting group title

1.125% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at doses of 1.125%

Reporting group title

1.5% Bamosiran

Reporting group description

Bamosiran, a 21-nucleotide siRNA for ocular administration (eye drops) once daily in each eye over a period of 28 days at doses of 1.5%

Reporting group title

0.5% Timolol

Reporting group description

Timolol maleate for ocular administration (eye drops) bid in each eye over a period of 28 days at a dose of 0.5%.

Serious adverse events	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 37 (0.00%)	0 / 40 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 37 (0.00%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0

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

Non-serious adverse events	0.375% Bamosiran	0.75% Bamosiran	1.125% Bamosiran	1.5% Bamosiran	0.5% Timolol
Total subjects affected by non serious adverse events
subjects affected / exposed	16 / 37 (43.24%)	18 / 40 (45.00%)	15 / 37 (40.54%)	10 / 33 (30.30%)	9 / 37 (24.32%)
Nervous system disorders
Headache
subjects affected / exposed	1 / 37 (2.70%)	1 / 40 (2.50%)	3 / 37 (8.11%)	1 / 33 (3.03%)	0 / 37 (0.00%)
occurrences all number	1	5	3	1	0
Eye disorders
Conjunctival hyperaemia
subjects affected / exposed	1 / 37 (2.70%)	0 / 40 (0.00%)	3 / 37 (8.11%)	2 / 33 (6.06%)	1 / 37 (2.70%)
occurrences all number	2	0	3	2	1
Eye pruritus
subjects affected / exposed	2 / 37 (5.41%)	1 / 40 (2.50%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 37 (2.70%)
occurrences all number	2	1	0	0	1
Lacrimation increased
subjects affected / exposed	0 / 37 (0.00%)	2 / 40 (5.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0
Ocular discomfort
subjects affected / exposed	0 / 37 (0.00%)	3 / 40 (7.50%)	0 / 37 (0.00%)	1 / 33 (3.03%)	0 / 37 (0.00%)
occurrences all number	0	3	0	1	0
Vision blurred
subjects affected / exposed	0 / 37 (0.00%)	2 / 40 (5.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	2	0	0	1
Gastrointestinal disorders
Toothache
subjects affected / exposed	0 / 37 (0.00%)	2 / 40 (5.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0
Instillation site pain
subjects affected / exposed	0 / 37 (0.00%)	0 / 40 (0.00%)	0 / 37 (0.00%)	0 / 33 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
Infections and infestations
Nasopharyngitis
subjects affected / exposed	2 / 37 (5.41%)	0 / 40 (0.00%)	1 / 37 (2.70%)	1 / 33 (3.03%)	0 / 37 (0.00%)
occurrences all number	2	0	1	1	0

More information

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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

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Clinical trials

Clinical Trial Results:
A phase II, observer masked, active controlled study of SYL040012 for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (SYLTAG)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Changes in diurnal IOP after 28 days of treatment

Primary: Changes in diurnal IOP after 28 days of treatment

Secondary: Changes in diurnal IOP after 14 days of treatment

Secondary: Changes in diurnal IOP after 14 days of treatment

Secondary: GQL-15 Questionnaire at Day 29

Secondary: GQL-15 Questionnaire at Day 29

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: A phase II, observer masked, active controlled study of SYL040012 for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (SYLTAG)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Changes in diurnal IOP after 28 days of treatment

Primary: Changes in diurnal IOP after 28 days of treatment

Secondary: Changes in diurnal IOP after 14 days of treatment

Secondary: Changes in diurnal IOP after 14 days of treatment

Secondary: GQL-15 Questionnaire at Day 29

Secondary: GQL-15 Questionnaire at Day 29

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A phase II, observer masked, active controlled study of SYL040012 for the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension (SYLTAG)