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

• Sponsor: Alexandria University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04455126
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 26
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Preservative-free tafluprost eye drops	Phase 2/Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure (IOP) [12 weeks]

   Intraocular pressure (IOP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Medicine	Alexandria		Egypt

Sponsors and Collaborators

• Alexandria University

Investigators

• Principal Investigator: Mohamed Doheim, Alexandria Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amir abou Samra, Prof., Alexandria University
• ClinicalTrials.gov Identifier: NCT04455126
• Other Study ID Numbers: 0105556
• First Posted: Jul 2, 2020
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Ophthalmic Solutions

Study Results

No Results Posted as of Jul 2, 2020