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The effect of preservative free tafluprost eye drops on intraocular pressure

An open, non-randomized study on the effect of preservative free tafluprost (Saflutan® Augentropfen) in patients with ocular hypertension or with primary open angle glaucoma with an uncontrolled intraocular pressure of 30 mmHg and more - Effect of saflutan on intraocular pressure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003157-16-AT
Enrollment
Unknown
Registered
2013-08-09
Start date
2013-08-27
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma or ocular hypertension MedDRA version: 14.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Saflutan Product Name: Saflutan Pharmaceutical Form: Eye drops INN or Proposed INN: Tafluprost Other descriptive name: TAFLUPROST Concentration unit: µg/ml microgram(s)/millilitre Concentr

Sponsors

Ordination Dr. Hommer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: + Patients with diagnosed primary open angle glaucoma and an untreated intraocular pressure of 30mmHg or more + Patients with ocular hypertension Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: + other ocular diseases except glaucoma + severe visual field defect + other severe medical conditions that will interfere with the subject of the trial

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the effect of saflutan eye drops on intraocular pressure;Secondary Objective: not applicable;Primary end point(s): Intraocular pressure;Timepoint(s) of evaluation of this end point: after 4 weeks and 8 weeks of treatment—

Secondary

MeasureTime frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable—

Countries

Austria

Contacts

Public ContactDr. Anton Hommer

Ordination Dr. Hommer

+431408347715

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026