Glaucoma, Primary Open AngleNCT04737928
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)
A study testing Latanoprost and tafluprost in people with Glaucoma, Primary Open Angle, run by Santen Pharmaceutical (Taiwan) Co., LTD at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle
- What is being tested?
- Latanoprost and tafluprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Apr 2018to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Glaucoma, Primary Open Angle
- Being tested
- Latanoprost, tafluprost
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
latanoprost 0.05%(one drop, once daily)
tafluprostDrug
tafluprost 0.015% (one drop, once daily)
| Study group | Role | What they receive |
|---|---|---|
| latanoprost switch to tafluprost | Experimental | 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. Receives: Drug: Latanoprost; Drug: tafluprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Changes in the Intraocular Pressure (IOP) at each visit
Tonometer
Measured: 3 months
Safety:Changes in the fluorescein staining score (NEI) at Visit 2
fluorescein staining
Measured: 3 months
Secondary outcomes (9)
Changes in the fluorescein staining score (NEI) at Visit 1
fluorescein staining
Measured: 1 months
Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit
Questionnaire
Measured: 3 months
Changes in the Tear Break-Up Time (TBUT) at each visit
slit-lamp
Measured: 3 months
Changes in the hyperaemia at each visit
slit-lamp
Measured: 3 months
Treatment compliance
Questionnaire
Measured: 3 months
Concomitant medication
Questionnaire
Measured: 3 months
Patient satisfaction about test medication
Questionnaire
Measured: 3 months
Usability of eyedrop bottle
Questionnaire
Measured: 3 months
Adverse drug reactions
Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Apr 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical (Taiwan) Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737928
- Sponsor's protocol ID
- TFT-IIR_TW001
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04737928
- Acronym / sponsor ID
- TFT-IIR_TW001
- Conditions
- Glaucoma, Primary Open Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Santen Pharmaceutical (Taiwan) Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| latanoprost switch to tafluprost | Experimental | Drug: Latanoprost, Drug: tafluprostPOAG 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprostlatanoprost 0.05%(one drop, once daily) | Drug | latanoprost switch to tafluprost |
| tafluprosttafluprost 0.015% (one drop, once daily) | Drug | latanoprost switch to tafluprost |
Primary outcome
Efficacy: Changes in the Intraocular Pressure (IOP) at each visit
Time frame: 3 months
Tonometer
Safety:Changes in the fluorescein staining score (NEI) at Visit 2
Time frame: 3 months
fluorescein staining
9 secondary outcomes
Changes in the fluorescein staining score (NEI) at Visit 1
Time frame: 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
Changes in the Tear Break-Up Time (TBUT) at each visit
Time frame: 3 months
Changes in the hyperaemia at each visit
Time frame: 3 months
Treatment compliance
Time frame: 3 months
Concomitant medication
Time frame: 3 months
Patient satisfaction about test medication
Time frame: 3 months
Usability of eyedrop bottle
Time frame: 3 months
Adverse drug reactions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost and tafluprost in people with Glaucoma, Primary Open Angle, run by Santen Pharmaceutical (Taiwan) Co., LTD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Changes in the Intraocular Pressure (IOP) at each visit (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.