CClinicalTrials.gg
CompletedNCT04737928Updated Feb 4, 2021

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)

An interventional study of Latanoprost and tafluprost in Glaucoma, Primary Open Angle, sponsored by Santen Pharmaceutical (Taiwan) Co., LTD. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by Santen Pharmaceutical (Taiwan) Co., LTD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Apr 2018, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 1 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Santen Pharmaceutical (Taiwan) Co., LTD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • 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 · Drug: tafluprost

Interventions

  • DrugLatanoprost

    latanoprost 0.05%(one drop, once daily)

  • Drugtafluprost

    tafluprost 0.015% (one drop, once daily)

06

What researchers measure

Primary outcomes

  1. Efficacy: Changes in the Intraocular Pressure (IOP) at each visit

    Tonometer

    Time frame: 3 months

  2. Safety:Changes in the fluorescein staining score (NEI) at Visit 2

    fluorescein staining

    Time frame: 3 months

Secondary outcomes

  1. Changes in the fluorescein staining score (NEI) at Visit 1

    fluorescein staining

    Time frame: 1 months

  2. Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit

    Questionnaire

    Time frame: 3 months

  3. Changes in the Tear Break-Up Time (TBUT) at each visit

    slit-lamp

    Time frame: 3 months

  4. Changes in the hyperaemia at each visit

    slit-lamp

    Time frame: 3 months

  5. Treatment compliance

    Questionnaire

    Time frame: 3 months

  6. Concomitant medication

    Questionnaire

    Time frame: 3 months

  7. Patient satisfaction about test medication

    Questionnaire

    Time frame: 3 months

  8. Usability of eyedrop bottle

    Questionnaire

    Time frame: 3 months

  9. Adverse drug reactions

    Questionnaire

    Time frame: 3 months

07

Study locations

1 site
  • Chi Mei Hospital Liouying Branch
    Tainan, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04737928
Lead sponsor
Santen Pharmaceutical (Taiwan) Co., LTD
Responsible party
Sponsor
First posted
Feb 4, 2021
Start date
Apr 2, 2018
Primary completion
Jan 22, 2019
Completion
Jan 22, 2019
Last update
Feb 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion