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Clinical Trial Results:
Dose- finding clinical trial with SYL040012 to evaluate the tolerability and effect on intraocular pressure in subjects with ocular hypertension or open-angle glaucoma

Summary
EudraCT number	2011-001849-33
Trial protocol	EE ES DE
Global end of trial date	30 Apr 2013

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_III

ISRCTN number

US NCT number

WHO universal trial number (UTN)

U1111-1126-6866

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., +34 918047667, info@sylentis.com

Scientific contact

Head of Regulatory Affairs & QP, Sylentis S.A.U., +34 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

26 Sep 2013

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Apr 2013

Global end of trial reached?

Yes

Global end of trial date

30 Apr 2013

Was the trial ended prematurely?

Main objective of the trial

Tolerability in the ocular surface (cornea and conjunctiva) and effect on intraocular pressure after a daily dose of the investigational product during 14 days of treatment

Protection of trial subjects

This clinical trial was conducted in compliance with Good Clinical Practice and the applicable national regulations to ensure that the rights and well-being of the participating subjects were protected consistent with the ethical principles that had their origin in the Declaration of Helsinki

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Jul 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 61

Country: Number of subjects enrolled

Estonia: 37

Country: Number of subjects enrolled

Germany: 26

Worldwide total number of subjects

124

EEA total number of subjects

124

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)

124

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 124 patients were screened from 18 July 2012 to 10 April 2013 in 11 centers in Spain, Germany and Estonia. A total of 35 patients were finally not included in the study.

Screening details

- Signed informed consent - Male and female subjects in good or fair general health - Age ≥18 years - Previous history or newly diagnosed IOP (≥21 mmHg) - Normal result, or result typical for open-angle glaucoma (Visual field 24-2 or equivalent, OCT, BCVA, Schirmer test ≥0.5 (20/40), funduscopy)

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

Drug packaging applied 5- digit identifiers to the vials containing investigational product. The medication identifier was a random number to ensure there was no link between each number and the investigational product that it related to. Both the labeling and the vials allowed to maintain the blinding throughout the study. Treatment assignment was performed according to a randomization list blinded both for the sponsor and the investigator.

Are arms mutually exclusive

Yes

SYL040012 80 μg

Arm description

Subjects received a daily administration of 1 drop in each of the eyes of 0.2% SYL040012 ophthalmic solution (80 μg) for 14 consecutive days

Arm type

Experimental

Investigational medicinal product name

SYL040012

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

SYL040012 was administered to both eyes into the conjunctival sac once daily for 14 days. The investigational product was administered at the site by a designated site personnel staff. Investigational product administration took place at the same time every day, with an allowance of ± 1 hour with respect to the previous administration.

SYL040012 300 μg

Arm description

Subjects received a daily administration of 1 drop in each of the eyes of 0.75% SYL040012 ophthalmic solution (300 μg) for 14 consecutive days

Arm type

Experimental

Investigational medicinal product name

SYL040012

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

SYL040012 900 μg

Arm description

Subjects received a daily administration of 1 drop in each of the eyes of 2.25% SYL040012 ophthalmic solution (900 μg) for 14 consecutive days

Arm type

Experimental

Investigational medicinal product name

SYL040012

Investigational medicinal product code

SYL040012

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Ophthalmic use

Dosage and administration details

Placebo

Arm description

Subjects received a daily administration of 1 drop in each of the eyes of placebo ophthalmic solution for 14 consecutive days

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Eye drops, solution

Routes of administration

Conjunctival use

Dosage and administration details

Doses of placebo were administered to both eyes once daily for 14 days.

Number of subjects in period 1 ^[1]	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Started	22	20	24	23
Completed	20	18	24	22
Not completed	2	2	0	1
Physician decision	-	1	-	-
Failure to return	-	1	-	-
Adverse event, non-fatal	1	-	-	-
IOP = 35 mmHg	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 35 patients were finally not included in the study due to the following reasons: Inclusion/Exclusion criteria (32) and Withdrawal of consent (3).

Baseline characteristics

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Reporting group title

SYL040012 80 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 0.2% SYL040012 ophthalmic solution (80 μg) for 14 consecutive days

Reporting group title

SYL040012 300 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 0.75% SYL040012 ophthalmic solution (300 μg) for 14 consecutive days

Reporting group title

SYL040012 900 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 2.25% SYL040012 ophthalmic solution (900 μg) for 14 consecutive days

Reporting group title

Placebo

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of placebo ophthalmic solution for 14 consecutive days

Reporting group values	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo	Total
Number of subjects	22	20	24	23	89
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	55.7 ± 12.65	58.2 ± 12.99	56.8 ± 15.71	59.9 ± 13.84	-
Gender categorical
Units: Subjects
Female	15	12	16	17	60
Male	7	8	8	6	29
Race
Units: Subjects
White	22	20	24	23	89
Weight
Units: Kg
arithmetic mean (standard deviation)	77.4 ± 17.55	81.9 ± 22.92	78.5 ± 14.83	75 ± 11.34	-
Height
Units: cm
arithmetic mean (standard deviation)	168 ± 9.71	166 ± 11.38	164 ± 10.11	165 ± 9.44	-
BMI
BMI=Body mass index
Units: kg/m2
arithmetic mean (standard deviation)	27.2 ± 5.13	29.3 ± 5.81	29.2 ± 5.25	27.6 ± 4.24	-
Temperature
Units: celsius temperature
arithmetic mean (standard deviation)	36.5 ± 0.41	36.5 ± 0.31	36.6 ± 0.31	36.5 ± 0.42	-

End points

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Reporting group title

SYL040012 80 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 0.2% SYL040012 ophthalmic solution (80 μg) for 14 consecutive days

Reporting group title

SYL040012 300 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 0.75% SYL040012 ophthalmic solution (300 μg) for 14 consecutive days

Reporting group title

SYL040012 900 μg

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of 2.25% SYL040012 ophthalmic solution (900 μg) for 14 consecutive days

Reporting group title

Placebo

Reporting group description

Subjects received a daily administration of 1 drop in each of the eyes of placebo ophthalmic solution for 14 consecutive days

Primary: Changes in IOP AUC

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End point title

Changes in IOP AUC

End point description

IOP AUC=The intraocular pressure area under curve

End point type

Primary

End point timeframe

The change from baseline in the area under the IOP curve on Day 14 was measured

End point values	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Number of subjects analysed	22	20	24	23
Units: AUC
arithmetic mean (standard deviation)
Right Eye	-36 ± 25.81	-53 ± 29.29	-21 ± 28.91	-42 ± 31.02
Left Eye	-45 ± 26.72	-55 ± 28.04	-30 ± 24.72	-37 ± 32.57

Differences between groups

Comparison groups

SYL040012 80 μg v SYL040012 300 μg v SYL040012 900 μg v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

Method

Parameter type

Mean differences (300μg vs 900μg)

Point estimate

-28.67

Confidence interval

level

95%

sides

2-sided

lower limit

-45.33

upper limit

-12.02

Notes
[1] - All groups showed a reduction in the intraocular pressure at the end of the study. SYL040012 300μg showed the highest reduction in the symptoms when compared to baseline. When treatment groups were compared, statistically significant differences were found in favor of SYL040012 300μg versus SYL040012 900μg : CI: -28.67 (LS Means: -45.33; -12.02)

Secondary: Change in the mean IOP

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End point title

Change in the mean IOP

End point description

End point type

Secondary

End point timeframe

Change from baseline in the mean IOP at Day 14

End point values	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Number of subjects analysed	22	20	24	23
Units: mmHg
arithmetic mean (confidence interval 95%)	-2.642 (-3.251 to -2.033)	-3.534 (-4.176 to -2.893)	-1.687 (-2.243 to -1.131)	-2.618 (-3.198 to -2.038)

Attachments

IOP change

Differences between groups

Comparison groups

SYL040012 80 μg v SYL040012 300 μg v SYL040012 900 μg v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[2]

Method

repeated measures analysis mixed model

Confidence interval

Notes
[2] - Pb-80: 0.024 (-0.817,0.865) p=0.955 Pb-300: 0.916 (0.051,1.781) p=0.038 Pb-900: -0.931 (-1.734,-0.128) p=0.024 300-80: -0.892 (-1.777,-0.008) p=0.048 300-900: -1.847 (-2.696,-0.999) p=<.001 80-900: -0.955 (-1.779,-0.131) p=0.024

Secondary: Local tolerability: Cornea

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End point title

Local tolerability: Cornea

End point description

The tolerability variable was categorized as: - Normal: No corneal or conjunctival alteration observed. - Grade 1: Symptomatic or minimally symptomatic alterations observed, but which did not require intervention or interfere with function. - Grade 2: Symptomatic alterations observed which interfered with the function but not with daily life, and required topical intervention. - Grade 3: Symptomatic alterations observed which interfered with daily life, and required surgical intervention. No dose limitation was found in any of the treatment groups. None of the patients reported any Grade 3 alterations in the corneal and conjunctival evaluation. All reactions were of grade 1 or normal except for one reaction of Grade 2 in the cornea of the right eye at Day 11 in one patient (4.2%) in the SYL040012 900 μg group. All treatments were well tolerated by all patients in any of the treatment groups

End point type

Secondary

End point timeframe

Cornea: Corneal epithelium using fluorescein and Bengal pink or lissamine green dye. From day 1 to day 15

End point values	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Number of subjects analysed	22	20	24	23
Units: number of subjects
Day 1 - Grade 1 (right eye)	0	0	0	1
Day 1 - Grade 1 (left eye)	0	0	1	1
Day 3 - Grade 1 (right eye)	1	0	1	0
Day 3 - Grade 1 (left eye)	1	0	0	0
Day 4 - Grade 1 (right eye)	0	0	1	1
Day 4 - Grade 1 (left eye)	1	0	0	1
Day 5 - Grade 1 (left eye)	1	1	0	0
Day 6 - Grade 1 (right eye)	1	0	1	0
Day 6 - Grade 1 (left eye)	2	0	1	0
Day 7 - Grade 1 (right eye)	0	0	0	2
Day 7 - Grade 1 (left eye)	0	1	0	2
Day 8 - Grade 1 (right eye)	1	1	1	1
Day 8 - Grade 1 (left eye)	1	1	1	1
Day 9 - Grade 1 (right eye)	0	1	0	0
Day 10 - Grade 1 (right eye)	0	0	0	1
Day 10 - Grade 1 (left eye)	0	0	0	1
Day 11 - Grade 2 (right eye)	0	0	1	0
Day 11 - Grade 1 (left eye)	0	0	1	0
Day 12 - Grade 1 (right eye)	0	0	2	2
Day 12 - Grade 1 (left eye)	0	0	2	2
Day 13 - Grade 1 (right eye)	0	0	1	1
Day 13 - Grade 1 (left eye)	0	0	1	1
Day 14 - Grade 1 (right eye)	0	0	1	1
Day 14 - Grade 1 (left eye)	0	0	0	1
Day 15 - Grade 1 (right eye)	0	0	1	1
Day 15 - Grade 1 (left eye)	0	0	0	2

No statistical analyses for this end point

Secondary: Local tolerability: Conjunctiva

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End point title

Local tolerability: Conjunctiva

End point description

End point type

Secondary

End point timeframe

Conjunctiva: Palpebral and bulbar conjunctival hyperemia. From day 1 to day 15

End point values	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Number of subjects analysed	22	20	24	23
Units: number of subjects
Day 1 - Grade 1 (right eye)	1	2	0	2
Day 1 - Grade 1 (left eye)	1	2	0	1
Day 2 - Grade 1 (right eye)	0	0	1	0
Day 3 - Grade 1 (right eye)	1	0	1	1
Day 3 - Grade 1 (left eye)	2	0	1	1
Day 4 - Grade 1 (right eye)	0	0	0	1
Day 4 - Grade 1 (left eye)	1	0	0	1
Day 5 - Grade 1 (left eye)	1	0	0	0
Day 6 - Grade 1 (right eye)	0	0	1	0
Day 6 - Grade 1 (left eye)	1	1	1	0
Day 7 - Grade 1 (right eye)	0	1	0	0
Day 7 - Grade 1 (left eye)	0	1	0	0
Day 8 - Grade 1 (right eye)	0	1	0	1
Day 8 - Grade 1 (left eye)	0	1	0	1
Day 9 - Grade 1 (right eye)	0	2	0	0
Day 9 - Grade 1 (left eye)	0	1	0	0
Day 10 - Grade 1 (right eye)	1	1	0	1
Day 10 - Grade 1 (left eye)	1	1	0	1
Day 11 - Grade 1 (right eye)	1	1	0	0
Day 11 - Grade 1 (left eye)	1	2	0	0
Day 12 - Grade 1 (right eye)	0	0	2	1
Day 12 - Grade 1 (left eye)	0	0	2	1
Day 13 - Grade 1 (right eye)	0	0	1	0
Day 13 - Grade 1 (left eye)	1	0	1	0
Day 14 - Grade 1 (left eye)	0	0	1	1

No statistical analyses for this end point

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

SYL040012 80 μg

Reporting group description

Doses of 80 μg SYL040012 were administered to both eyes once daily for 14 days.

Reporting group title

SYL040012 300 μg

Reporting group description

Doses of 300 μg SYL040012 were administered to both eyes once daily for 14 days.

Reporting group title

SYL040012 900 μg

Reporting group description

Doses of 900 μg SYL040012 were administered to both eyes once daily for 14 days.

Reporting group title

Placebo

Reporting group description

Doses of placebo were administered to both eyes once daily for 14 days.

Serious adverse events	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Metabolism and nutrition disorders
Hyponatraemia
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	SYL040012 80 μg	SYL040012 300 μg	SYL040012 900 μg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	10 / 22 (45.45%)	9 / 20 (45.00%)	12 / 24 (50.00%)	4 / 23 (17.39%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0
Vascular disorders
Hyperaemia
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Hypertensive crisis
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Pyrexia
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Oropharyngeal pain
subjects affected / exposed	1 / 22 (4.55%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	1	0	0
Investigations
Catheterisation cardiac
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Injury, poisoning and procedural complications
Eye burns
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Foreign body in eye
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	1 / 23 (4.35%)
occurrences all number	0	0	1	1
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Nervous system disorders
Headache
subjects affected / exposed	2 / 22 (9.09%)	1 / 20 (5.00%)	5 / 24 (20.83%)	3 / 23 (13.04%)
occurrences all number	4	3	6	3
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Eye disorders
Conjunctival haemorrhage
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	0 / 24 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	1
Conjunctival hyperaemia
subjects affected / exposed	2 / 22 (9.09%)	0 / 20 (0.00%)	2 / 24 (8.33%)	1 / 23 (4.35%)
occurrences all number	4	0	2	5
Conjunctival oedema
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	0 / 24 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	1
Dry eye
subjects affected / exposed	1 / 22 (4.55%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	1	0	0
Eye pain
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	2 / 24 (8.33%)	0 / 23 (0.00%)
occurrences all number	0	0	4	0
Eye pruritus
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0
Lacrimation increased
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	0 / 24 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	1
Ocular discomfort
subjects affected / exposed	0 / 22 (0.00%)	3 / 20 (15.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	3	0	0
Punctate keratitis
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	1 / 24 (4.17%)	1 / 23 (4.35%)
occurrences all number	2	0	4	4
Vision blurred
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	2 / 23 (8.70%)
occurrences all number	0	0	1	2
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Back pain
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Joint swelling
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Cystitis
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	1	0	1
Nasopharyngitis
subjects affected / exposed	1 / 22 (4.55%)	1 / 20 (5.00%)	0 / 24 (0.00%)	2 / 23 (8.70%)
occurrences all number	3	1	0	2
Oral herpes
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	1 / 24 (4.17%)	0 / 23 (0.00%)
occurrences all number	0	0	1	0
Sinusitis
subjects affected / exposed	1 / 22 (4.55%)	0 / 20 (0.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	1	0	0	0
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	0 / 22 (0.00%)	1 / 20 (5.00%)	0 / 24 (0.00%)	0 / 23 (0.00%)
occurrences all number	0	1	0	0
Hyperglycaemia
subjects affected / exposed	0 / 22 (0.00%)	0 / 20 (0.00%)	0 / 24 (0.00%)	1 / 23 (4.35%)
occurrences all number	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

06 Jul 2012

There was a non-substantial protocol amendment which included the following modifications: • Modification of the inclusion criteria no. 5 • Ocular fundus / fundus photography done on Day 15 • Subjective baseline visual analogue scale assessment • Modification of the exclusion criteria no. 17 • Dye to be used in corneal examination

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:
Dose- finding clinical trial with SYL040012 to evaluate the tolerability and effect on intraocular pressure in subjects with ocular hypertension or open-angle glaucoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Changes in IOP AUC

Primary: Changes in IOP AUC

Secondary: Change in the mean IOP

Secondary: Change in the mean IOP

Secondary: Local tolerability: Cornea

Secondary: Local tolerability: Cornea

Secondary: Local tolerability: Conjunctiva

Secondary: Local tolerability: Conjunctiva

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
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Clinical trials

Clinical Trial Results: Dose- finding clinical trial with SYL040012 to evaluate the tolerability and effect on intraocular pressure in subjects with ocular hypertension or open-angle glaucoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Changes in IOP AUC

Primary: Changes in IOP AUC

Secondary: Change in the mean IOP

Secondary: Change in the mean IOP

Secondary: Local tolerability: Cornea

Secondary: Local tolerability: Cornea

Secondary: Local tolerability: Conjunctiva

Secondary: Local tolerability: Conjunctiva

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Dose- finding clinical trial with SYL040012 to evaluate the tolerability and effect on intraocular pressure in subjects with ocular hypertension or open-angle glaucoma