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)

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: Latanoprost; Drug: tafluprost

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Chi Mei Hospital Liouying Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: latanoprost switch to tafluprost; 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.	Drug: Latanoprost; latanoprost 0.05%(one drop, once daily); Drug: tafluprost; tafluprost 0.015% (one drop, once daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Changes in the Intraocular Pressure (IOP) at each visit	Tonometer	3 months
Safety:Changes in the fluorescein staining score (NEI) at Visit 2	fluorescein staining	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the fluorescein staining score (NEI) at Visit 1	fluorescein staining	1 months
Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit	Questionnaire	3 months
Changes in the Tear Break-Up Time (TBUT) at each visit	slit-lamp	3 months
Changes in the hyperaemia at each visit	slit-lamp	3 months
Treatment compliance	Questionnaire	3 months
Concomitant medication	Questionnaire	3 months
Patient satisfaction about test medication	Questionnaire	3 months
Usability of eyedrop bottle	Questionnaire	3 months
Adverse drug reactions	Questionnaire	3 months

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical (Taiwan) Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): January 22, 2019

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Corneal Diseases; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: TFT-IIR_TW001

Drug and device information, study documents

• 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