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Tafluprost Preservative Free Switch Study

Primary Purpose

Glaucoma, Primary Open Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Malaysia

Study Type

Interventional

Intervention

preservative free tafluprost 0.0015%

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age of 21 years or older and those who can provide informed consent.
Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months.
Outpatients who can visit the clinic on the designated day as instructed by the physician.
A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye.

Exclusion Criteria:

Those with severe visual field disorder (Mean deviation of 15 dB or worse)
Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution
Female patients who are pregnant, nursing or lactating
Those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the investigational product
Those who need to wear contact lenses during the study period
Any corneal abnormality or other condition preventing reliable applanation tonometry
Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy
Any uncontrolled systemic disease (e.g. hypertension, diabetes)

Sites / Locations

THONEH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment group

Arm Description

The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration.

Outcomes

Primary Outcome Measures

Changes in the fluorescein staining score (NEI) at Visit 2

The fluorescein stained area of the cornea will be measured according to the National Eye Institute/Industry (NEI/I) method. NEI grading scale consists of a grid that divides the corneal area into five sections, each of which is assigned a score between zero and 3 depending of the amount and distribution of Corneal Fluorescein Stain (CFS); the total CFS score ranges from 0/15 (absence of corneal epitheliopathy) to 15/15 (severe epitheliopathy)

Secondary Outcome Measures

Full Information

NCT ID

NCT04654611

First Posted

November 23, 2020

Last Updated

December 1, 2020

Sponsor

Tun Hussein Onn National Eye Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04654611

Brief Title

Tafluprost Preservative Free Switch Study

Official Title

Ocular Surface Conditions in Asian Glaucoma Patients With Existing Corneal Disorders Switching From Preserved Prostaglandin Analogues Monotherapy to Preservative-free Tafluprost

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tun Hussein Onn National Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.

Detailed Description

Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases. Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases. Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital. Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1. Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2). Main Outcome Measures: The main parameter measured is the change in the fluorescein staining score at Visit 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Other

Arm Description

The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration.

Intervention Type

Drug

Intervention Name(s)

preservative free tafluprost 0.0015%

Intervention Description

preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients

Primary Outcome Measure Information:

Title

Changes in the fluorescein staining score (NEI) at Visit 2

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age of 21 years or older and those who can provide informed consent. Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale) Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment) If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation. Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months. Outpatients who can visit the clinic on the designated day as instructed by the physician. A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye. Exclusion Criteria: Those with severe visual field disorder (Mean deviation of 15 dB or worse) Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation. Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution Female patients who are pregnant, nursing or lactating Those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the investigational product Those who need to wear contact lenses during the study period Any corneal abnormality or other condition preventing reliable applanation tonometry Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy Any uncontrolled systemic disease (e.g. hypertension, diabetes)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsien Han Lim

Organizational Affiliation

Tun Hussein Onn National Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

THONEH

City

Petaling Jaya

State/Province

Selangor Darul Ehsan

ZIP/Postal Code

46200

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

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Tafluprost Preservative Free Switch Study

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