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Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders (Switching From 0.005% Latanoprost Ophthalmic Solution)

Primary Purpose

Glaucoma, Primary Open Angle

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Latanoprost
tafluprost
Sponsored by
Santen Pharmaceutical (Taiwan) Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle

Eligibility Criteria

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

Inclusion Criteria:

  • Age of 20 years or older and those who was provided informed consent.
  • POAG or OH patients whose IOP did not exceed 22 mmHg at Visit 0.
  • Patients had treated with prostaglandin ophthalmic solution (0.005% Latanoprost) for at least 3 months before enrollment.
  • Patients who had corneal disorders due to the PG usage. (At least one eye had a score above 1 on the NEI scale)
  • If only one eye was eligible, it was evaluated. When both eyes were eligible, then the eye with a higher NEI score was selected for evaluation.
  • Outpatients who visited the clinic on the designated day as instructed by the physician.

Exclusion Criteria:

  • Those with severe visual field disorder (Mean deviation of 15 dB or worse).
  • Those who received corneal refractive surgery.
  • Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which affected the patient's ocular surface condition) within 3 months prior to enrollment.
  • Any corneal abnormality or other condition preventing IOP measurement.
  • Those who used artificial tears to relieve dry eye symptoms.
  • Those with severe dry eye, ocular allergy, ocular infection or ocular inflammation which considered affect interpretation of the results of the study. Those who used systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than prostaglandin ophthalmic solution.
  • Female patients who were 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 study medication.
  • Those who wore contact lenses during the study period.
  • Those who had participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.

Sites / Locations

  • Chi Mei Hospital Liouying Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

latanoprost switch to tafluprost

Arm Description

POAG and OH patients prescribed latanoprost(QID) at least 3 months (IOP>20). At least one eye must have a score above 1 on the NEI scale. Switch to latanoprost (QID) for 3 months.

Outcomes

Primary Outcome Measures

Efficacy: Changes in the Intraocular Pressure (IOP) at each visit
Tonometer
Safety:Changes in the fluorescein staining score (NEI) at Visit 2
fluorescein staining

Secondary Outcome Measures

Changes in the fluorescein staining score (NEI) at Visit 1
fluorescein staining
Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit
Questionnaire
Changes in the Tear Break-Up Time (TBUT) at each visit
slit-lamp
Changes in the hyperaemia at each visit
slit-lamp
Treatment compliance
Questionnaire
Concomitant medication
Questionnaire
Patient satisfaction about test medication
Questionnaire
Usability of eyedrop bottle
Questionnaire
Adverse drug reactions
Questionnaire

Full Information

First Posted
January 28, 2021
Last Updated
February 3, 2021
Sponsor
Santen Pharmaceutical (Taiwan) Co., LTD
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1. Study Identification

Unique Protocol Identification Number
NCT04737928
Brief Title
Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders (Switching From 0.005% Latanoprost Ophthalmic Solution)
Official Title
Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical (Taiwan) Co., LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to investigate the improving effect of corneal disorder in primary open-angle glaucoma and ocular hypertension patients, when switched from the 0.005% latanoprost ophthalmic solution (one drop at a time, once daily) to the 0.0015% tafluprost ophthalmic solution (one drop at a time, once daily). Efficacy also was investigated.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
latanoprost switch to tafluprost
Arm Type
Experimental
Arm Description
POAG and OH patients prescribed latanoprost(QID) at least 3 months (IOP>20). At least one eye must have a score above 1 on the NEI scale. Switch to latanoprost (QID) for 3 months.
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
latanoprost 0.05%(one drop, once daily)
Intervention Type
Drug
Intervention Name(s)
tafluprost
Intervention Description
tafluprost 0.015% (one drop, once daily)
Primary Outcome Measure Information:
Title
Efficacy: Changes in the Intraocular Pressure (IOP) at each visit
Description
Tonometer
Time Frame
3 months
Title
Safety:Changes in the fluorescein staining score (NEI) at Visit 2
Description
fluorescein staining
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in the fluorescein staining score (NEI) at Visit 1
Description
fluorescein staining
Time Frame
1 months
Title
Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit
Description
Questionnaire
Time Frame
3 months
Title
Changes in the Tear Break-Up Time (TBUT) at each visit
Description
slit-lamp
Time Frame
3 months
Title
Changes in the hyperaemia at each visit
Description
slit-lamp
Time Frame
3 months
Title
Treatment compliance
Description
Questionnaire
Time Frame
3 months
Title
Concomitant medication
Description
Questionnaire
Time Frame
3 months
Title
Patient satisfaction about test medication
Description
Questionnaire
Time Frame
3 months
Title
Usability of eyedrop bottle
Description
Questionnaire
Time Frame
3 months
Title
Adverse drug reactions
Description
Questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 20 years or older and those who was provided informed consent. POAG or OH patients whose IOP did not exceed 22 mmHg at Visit 0. Patients had treated with prostaglandin ophthalmic solution (0.005% Latanoprost) for at least 3 months before enrollment. Patients who had corneal disorders due to the PG usage. (At least one eye had a score above 1 on the NEI scale) If only one eye was eligible, it was evaluated. When both eyes were eligible, then the eye with a higher NEI score was selected for evaluation. Outpatients who visited the clinic on the designated day as instructed by the physician. Exclusion Criteria: Those with severe visual field disorder (Mean deviation of 15 dB or worse). Those who received corneal refractive surgery. Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which affected the patient's ocular surface condition) within 3 months prior to enrollment. Any corneal abnormality or other condition preventing IOP measurement. Those who used artificial tears to relieve dry eye symptoms. Those with severe dry eye, ocular allergy, ocular infection or ocular inflammation which considered affect interpretation of the results of the study. Those who used systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than prostaglandin ophthalmic solution. Female patients who were 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 study medication. Those who wore contact lenses during the study period. Those who had participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.
Facility Information:
Facility Name
Chi Mei Hospital Liouying Branch
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

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Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders (Switching From 0.005% Latanoprost Ophthalmic Solution)

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