Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma

Alexandria University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glaucoma

Treatments: Drug: Preservative-free tafluprost eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT04455126

0105556

Details and patient eligibility

About

Glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss

Full description

Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian market. It contains the PG analog tafluprost. Better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index (OSDI) questionnaire, and able to provide informed consent form.

Exclusion criteria

• Unable to provide informed consent form

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Preservative-free tafluprost

Experimental group

Description:

This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops

Treatment:

Drug: Preservative-free tafluprost eye drops