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

NCT ID: NCT04455126

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preservative-free tafluprost

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

Group Type EXPERIMENTAL

Preservative-free tafluprost eye drops

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Amir abou Samra

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Doheim

Role: PRINCIPAL_INVESTIGATOR

Alexandria Faculty of Medicine

Locations

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Alexandria Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0105556

Identifier Type: -

Identifier Source: org_study_id

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