- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737928
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)
February 3, 2021 updated by: Santen Pharmaceutical (Taiwan) Co., LTD
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan
- Chi Mei Hospital Liouying Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
latanoprost 0.05%(one drop, once daily)
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
Time Frame: 3 months
|
Tonometer
|
3 months
|
Safety:Changes in the fluorescein staining score (NEI) at Visit 2
Time Frame: 3 months
|
fluorescein staining
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the fluorescein staining score (NEI) at Visit 1
Time Frame: 1 months
|
fluorescein staining
|
1 months
|
Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Changes in the Tear Break-Up Time (TBUT) at each visit
Time Frame: 3 months
|
slit-lamp
|
3 months
|
Changes in the hyperaemia at each visit
Time Frame: 3 months
|
slit-lamp
|
3 months
|
Treatment compliance
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Concomitant medication
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Patient satisfaction about test medication
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Usability of eyedrop bottle
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Adverse drug reactions
Time Frame: 3 months
|
Questionnaire
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glaucoma, Primary Open Angle
-
Omar SaidCompletedGlaucoma,Primary Open-Angle ,Primary Angle ClosureEgypt
-
Peking UniversityRecruitingPrimary Open Angle Glaucoma | Ocular Hypertension | Primary Open Angle Glaucoma of Both Eyes | Primary Open-Angle Glaucoma, Unspecified Eye | Suspect GlaucomaChina
-
Glaucot Teknoloji Anonim SirketiRecruitingPrimary Open-Angle GlaucomaTurkey
-
China Medical University HospitalCompletedEffect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle GlaucomaPrimary Open-angle GlaucomaTaiwan
-
InnFocus Inc.CompletedPrimary Open-angle GlaucomaSpain, United States, United Kingdom, France, Italy
-
Glaukos CorporationTerminatedPrimary Open-Angle GlaucomaUnited States
-
Rehab mahmoud abdelhamid mohamedCairo UniversityCompletedPrimary Open-angle GlaucomaEgypt
-
Cairo UniversityUniversity of LuebeckUnknown
-
Xiaodong ZhouCompletedPrimary Open-angle Glaucoma
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
Clinical Trials on Latanoprost
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPrimary Open Angle Glaucoma | Ocular HypertensionUnited Kingdom, France, Australia, Thailand, Portugal, Pakistan, Czechia, Greece
-
Inotek Pharmaceuticals CorporationCompletedOcular Hypertension (OHT) | Primary Open-Angle Glaucoma (POAG)United States
-
PfizerCompletedOcular Hypertension | Glaucoma, Open-AngleUnited States
-
CHA UniversitySamil Pharmaceutical Co., Ltd.CompletedOcular Hypertension | GlaucomaKorea, Republic of
-
Massachusetts Eye and Ear InfirmaryHarvard UniversityRecruitingOcular Hypertension | GlaucomaUnited States
-
Dr. David YanAllerganUnknownPrimary Open Angle Glaucoma | Ocular Hypertension | POAGCanada
-
Rigshospitalet, DenmarkLaboratoires TheaRecruitingOcular Hypertension | GlaucomaDenmark
-
CHU de Quebec-Universite LavalTerminatedPrimary Open Angle Glaucoma | Ocular HypertensionCanada
-
Bausch & Lomb IncorporatedCompletedPrimary Open Angle Glaucoma | Ocular HypertensionJapan
-
Singapore National Eye CentreAllerganUnknownGlaucoma, Angle-ClosureSingapore