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NCT04455126 Clinical Trial

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

Glaucoma Clinical Trial

Official title:
Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04455126
Other study ID # 0105556
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 1, 2018
Est. completion date June 1, 2020

Study information
Verified date June 2020
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 1, 2020
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Preservative-free tafluprost eye drops
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

Locations
Country Name City State
Egypt Alexandria Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure (IOP) Intraocular pressure (IOP) 12 weeks
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