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)

Sponsor

Santen Pharmaceutical (Taiwan) Co., LTD (Industry)

Overall Status

Completed

CT.gov ID

NCT04737928

Collaborator

(none)

Enrollment

Location

Arm

9.7

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle	Drug: Latanoprost Drug: tafluprost	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 2, 2018

Actual Primary Completion Date :

Jan 22, 2019

Actual Study Completion Date :

Jan 22, 2019

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Efficacy: Changes in the Intraocular Pressure (IOP) at each visit [3 months]
Tonometer
Safety:Changes in the fluorescein staining score (NEI) at Visit 2 [3 months]
fluorescein staining

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.