Clinical Trial Results:
An open, non-randomized study on the effect of changing from preserved prostaglandin formulations to preservative free tafluprost (Saflutan® Augentropfen) in patients with ocular hypertension or primary open angle glaucoma on tear film thickness

Trial information Top of page
Trial identification
Sponsor protocol code	HOM1-2015
Additional study identifiers
ISRCTN number	-
US NCT number	NCT03204487
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Ordination Dr. Hommer
Sponsor organisation address	Albertgasse 39, Vienna, Austria, 1080
Public contact	Anton Hommer, Ordination Dr. Hommer, a.hommer@aon.at
Scientific contact	Anton Hommer, Ordination Dr. Hommer, a.hommer@aon.at
Paediatric regulatory details
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
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	25 Apr 2017
Is this the analysis of the primary completion data?	Yes
Primary completion date	25 Apr 2017
Global end of trial reached?	Yes
Global end of trial date	25 Apr 2017
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To test the hypothesis that changing patients who are on preserved prostaglandin formulations to preservative free tafluprost may be associated with an increase in ocular tear film thickness.
Protection of trial subjects	Questioning about Adverse Events on the study day.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	01 Jan 2016
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Austria: 30
Worldwide total number of subjects	30
EEA total number of subjects	30
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)	13
From 65 to 84 years	17
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Patients were recruited from Ordination Dr. Hommer.
Pre-assignment
Screening details	All outcome parameters were measured between 8am and 11pm. At baseline, patients were studied after instilling their evening dose of their preserved prostaglandin formulation at the day before. After completion of the baseline visit, eligible patients were switched from preserved prostaglandin formulations to Saflutan® eye drops.
Period 1
Period 1 title	Study period (overall period)
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Arm title	Patients with glaucoma or ocular hypertension
Arm description	Patients received Saflutan eye drops from Visit 1 to Visit 3.
Arm type	Experimental
Investigational medicinal product name	Saflutan eye drops
Investigational medicinal product code
Other name
Pharmaceutical forms	Eye drops
Routes of administration	Ocular use
Dosage and administration details	1 drop of tafluprost 15µg/ml (Saflutan® 15 Mikrogramm/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien) once daily in the study eye administered in the evening
Number of subjects in period 1 Patients with glaucoma or ocular hypertension Started 30 Completed 30

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Study period
Reporting group description	-
Reporting group values Study period Total Number of subjects 30 30 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) 13 13     From 65-84 years 17 17     85 years and over 0 0 Gender categorical Units: Subjects     Female 18 18     Male 12 12
Subject analysis sets
Subject analysis set title	Patients included in the study
Subject analysis set type	Per protocol
Subject analysis set description	Analysis was done per protocol
Subject analysis sets values Patients included in the study Number of subjects 30 Age categorical Units: Subjects     In utero 0     Preterm newborn infants (gestational age < 37 wks) 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) 13     From 65-84 years 17     85 years and over 0 Age continuous Units:      ± Gender categorical Units: Subjects     Female 18     Male 12

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Patients with glaucoma or ocular hypertension
Reporting group description	Patients received Saflutan eye drops from Visit 1 to Visit 3.
Subject analysis set title	Patients included in the study
Subject analysis set type	Per protocol
Subject analysis set description	Analysis was done per protocol

End points Top of page

Primary: Tear Film Thickness Top of page
End point title	Tear Film Thickness
End point description
End point type	Primary
End point timeframe	Change in tear film thickness from Visit 1 to Visit 3.
End point values Patients with glaucoma or ocular hypertension Patients included in the study Number of subjects analysed 30 30 Units: µm 30 30
Statistical analysis title	Change in TFT
Comparison groups	Patients with glaucoma or ocular hypertension v Patients included in the study
Number of subjects included in analysis	60
Analysis specification	Pre-specified
Analysis type	other
P-value	≤ 0.05
Method	t-test, 2-sided
Parameter type	Mean difference (final values)
Confidence interval
level	95%
sides	2-sided
lower limit	-
upper limit	-

Primary: Tear Film Thickness Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	From Screening to last visit.
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	22.0
Reporting groups
Reporting group title	Patients included in the study
Reporting group description	-
Serious adverse events Patients included in the study Total subjects affected by serious adverse events      subjects affected / exposed 0 / 30 (0.00%)      number of deaths (all causes) 0      number of deaths resulting from adverse events 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Patients included in the study Total subjects affected by non serious adverse events      subjects affected / exposed 27 / 30 (90.00%) Vascular disorders Arterial hypertension      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Cardiac disorders Atrial fibrillation      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Nervous system disorders Headache      subjects affected / exposed 6 / 30 (20.00%)      occurrences all number 6 Migraine      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Eye disorders Hyposphagma      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Eye irritation      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Visual acuity reduced      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Vision blurred      subjects affected / exposed 2 / 30 (6.67%)      occurrences all number 2 eye itching      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Foreign body sensation in eyes      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 burning eyes      subjects affected / exposed 2 / 30 (6.67%)      occurrences all number 1 Respiratory, thoracic and mediastinal disorders Dyspnoea      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Rhinitis      subjects affected / exposed 2 / 30 (6.67%)      occurrences all number 2 Cough      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 common cold      subjects affected / exposed 2 / 30 (6.67%)      occurrences all number 1 Renal and urinary disorders Urinary tract infection      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Musculoskeletal and connective tissue disorders Neck pain      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1 Back pain      subjects affected / exposed 1 / 30 (3.33%)      occurrences all number 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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