A study to assess the effect on an anti-glaucoma drug on the ocular tear film

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004012-37-AT

Enrollment

Registered

2015-11-11

Start date

2015-12-18

Completion date

Unknown

Last updated

2018-01-08

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

Conditions

Glaucoma / Ocular Hypertension MedDRA version: 18.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Saflutan Pharmaceutical Form: Ear/eye drops, solution INN or Proposed INN: N/A CAS Number: 209860-87-7 Current Sponsor code: Saflutan Other descriptive name: TAFLUPROST Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with either •primary open angle glaucoma treated with preserved prostaglandin formulations •ocular hypertension treated with preserved prostaglandin formulations 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ocular diseases other than glaucoma or ocular hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: not applicable;Primary end point(s): Tear film thickness measured at the end of the treatment period;Timepoint(s) of evaluation of this end point: 84 days after treatment start	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: not applicable;Primary end point(s): Tear film thickness measured at the end of the treatment period;Timepoint(s) of evaluation of this end point: 84 days after treatment start

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactAnton Hommer

Ordination Dr. Hommer

a.hommer@aon.at

Outcome results

None listed

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