A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03204487
• Date of registration: 23/06/2017
• Prospective Registration: No
• Primary sponsor: Ordination Dr. Hommer
• Public title: A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness
• Scientific title: 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
• Date of first enrolment: May 10, 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03204487
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women aged over 18 years

- Diagnosed primary open angle glaucoma treated with preserved prostaglandins for at
least 6 months OR

- Patients with ocular hypertension treated with preserved prostaglandins for at least 6
months

- IOP = 21 mmHg in the study eye at the screening examination (under treatment)

- Mean TFT at the screening visit = 6µm in the study eye

- At least 2 symptoms of dry eye syndrome in the study eye (itching, stinging, blurred
vision, foreign body sensation, debris, conjunctival redness) since at least one month

- Tear break up time = 10sec

Exclusion Criteria:

- Participation in a clinical trial in the 3 weeks before the screening visit

- Severe visual field loss as defined as an MD of -15 or worse in the study eye

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- Presence or history of a severe medical condition that will interfere with the study
aim as judged by the clinical investigator

- Sjögren's syndrome

- Stevens-Johnson syndrome

- Presence or history of a severe ocular condition that will interfere with the study
aim as judged by the clinical investigator

- Presence or history of allergic conjunctivitis

- Treatment with corticosteroids in the 4 weeks preceding the study

- Wearing of contact lenses

- Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except
glaucoma medication or topical lubricants

- Ocular infection

- Ocular surgery in the 6 months preceding the study (except laser trabeculoplasty)

- Pregnancy, planned pregnancy or lactating

- Contraindication against the use of topical prostaglandin therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glaucoma, Open-Angle

Ocular Hypertension

Intervention(s)

Drug: Tafluprost 15µg/ml

Primary Outcome(s)

Tear film thickness [Time Frame: Change from baseline tear film thickness at 4 and 12 weeks]

Secondary Outcome(s)

Corneal fluorescein staining [Time Frame: Change from baseline corneal fluorescein staining at 4 and 12 weeks]

Schirmer Test 1 [Time Frame: Change from Schirmer Test 1 at 4 and 12 weeks]

Intraocular pressure (IOP) [Time Frame: Change from baseline IOP at 4 and 12 weeks]

Tear Break Up Time (BUT) [Time Frame: Change from baseline BUT at 4 and 12 weeks]

Dry-Eye Related Quality of Life Score (DEQS) [Time Frame: Change from baseline DEQS at 4 and 12 weeks]

Ocular Surface Disease Index (OSDI) [Time Frame: Change from baseline OSDI at 4 and 12 weeks]

Tear film osmolarity [Time Frame: Change from baseline tear film osmolarity at 4 and 12 weeks]

Secondary ID(s)

HOM1-2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors