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Ocular Surface DiseaseNCT04828057

Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting

An observational study of Ocular Surface Disease and Primary Open Angle Glaucoma, run by Santen Pharmaceutical (Taiwan) Co., LTD at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT)… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Tafluprost, timolol maleate
How many people
50 participants
Where
1 siteTaiwan
Study dates
1 Sep 2021to 24 Aug 2022
Phase
Observational
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

Study population: The target population for the current study is all eligible patients who received at least one prescription of Tafluprost / Timolol in Taiwan; however, the sample population will be limited to eligible patients in the clinics included in the study

Who may be able to join

  • Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
  • According to the approved indications of Tafluprost / Timolol as indicated in the SPC
  • Male or female patients ≥20 years of age at time of informed consent
  • Diagnosis of open angle glaucoma or ocular hypertension
  • Insufficient IOP control with a monotherapy utilizing topical prostaglandin analogues, necessitating the use of a combination therapy according to the judgement of the treating ophthalmologist
  • Patient judged by their physician to benefit from preservative free eye drops
  • Not used Tafluprost / Timolol before

Who cannot join

  • Patient pregnant or nursing
  • Pregnancy planned in the following 6 months
  • Presence of contraindications as listed in the SPC
  • Any ophthalmologic surgery within 6 months prior to the study
  • Participation in any other investigational study within 30 days prior to enrolment

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

    Taoyuan City, 333012

Other trials in Taiwan

About this study

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

Read the detailed description

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

This study will include adults with open angle glaucoma or ocular hypertension, who received their first Tafluprost / Timolol prescription at baseline, even if Tafluprost / Timolol was not continued after the first prescription. In addition, patients must have their IOP recorded within 7 days before their first prescription of Tafluprost / Timolol, in order to be eligible for this study. Only those who provide informed consent will be included.

At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the patient is included in the study and relevant data will be recorded during routine clinical visits. Participation in this study is entirely voluntary; any patient may withdraw consent to participate in this study at any time. The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.

Being tested
Tafluprost, timolol maleate
Keywords
tafluprost, Tapcom-s, switching
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.

  • Tafluprost, timolol maleateDrug

    Also called latanoprost, tafluprost, bimatoprost, travoprost

    Patients prescribe PG mono who occurs OSD or I IOP lower insufficient. patients switch to combination therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change of intraocular pressure (IOP)

    The primary endpoint will be assessed for the whole patient group and separately in specific subgroups according to their last glaucoma treatments before initiating Tafluprost / Timolol. Classification of prior therapy

    Measured: 6 months post initiation

Secondary outcomes (18)

  1. Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks

    Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks of treatment from initiation

    Measured: from baseline to after 4 and 12 weeks of treatment from initiation

  2. Proportion of responders at 12 weeks, defined as change from baseline IOP of 20% or more

    Proportion of responders at 12 weeks,defined as change from baseline IOP of 20% or more

    Measured: 12 weeks post initiation

  3. Evaluation of clinical signs with Tafluprost / Timolol

    • Change in conjunctival hyperaemia distribution by severity

    Measured: 6 months post initiation

  4. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Dry eye

    Measured: 6 months post initiation

  5. Evaluation of the effectiveness (IOP-development) of Tafluprost / Timolol by the physician as measured by change in distribution by severity

    • Better than prior medication
    • Same as prior medication
    • Worse than prior medication

    Measured: 6 months post initiation

  6. Evaluation of clinical signs during therapy with Tafluprost / Timolol by the physician as measured by change in distribution by severity

    • Better than prior medication
    • Same as prior medication
    • Worse than prior medication

    Measured: 6 months post initiation

  7. Evaluation of tolerability of Tafluprost / Timolol by the Patient as measured by change in distribution by severity

    • Very good
    • Good
    • Satisfactorily
    • Poor

    Measured: 6 months post initiation

  8. Physician assessment of patient compliance compared to previous therapy

    • Better
    • Equal
    • Worse

    Measured: 6 months post initiation

  9. Concomitant therapy for glaucoma

    Record concomitant therapy from baseline to 6 months post initiation

    Measured: 6 months post initiation

  10. Evaluation of clinical signs with Tafluprost / Timolol

    • Change in corneal fluorescein staining (CFS) distribution by severity. Optional

    Measured: 6 months post initiation

  11. Evaluation of clinical signs with Tafluprost / Timolol

    • Mean change in Visual acuity (VA)

    Measured: 6 months post initiation

  12. Evaluation of clinical signs with Tafluprost / Timolol

    • Mean change in Schirmer's test. Optional

    Measured: 6 months post initiation

  13. Evaluation of clinical signs with Tafluprost / Timolol

    • Mean change in tear break up time (TBUT). Optional

    Measured: 6 months post initiation

  14. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Irritation

    Measured: 6 months post initiation

  15. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Itching eyes

    Measured: 6 months post initiation

  16. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Foreign body sensation

    Measured: 6 months post initiation

  17. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Eye pain

    Measured: 6 months post initiation

  18. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.

    • Other

    Measured: 6 months post initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completion24 Aug 2022
  4. Study completion24 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04828057
Sponsor's protocol ID
TW-VISIONARY Study
Status last verified
Oct 2022
First submitted
22 Mar 2021
Last updated
31 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ocular Surface Disease and Primary Open Angle Glaucoma, 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 7 inclusion and 5 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 31 Oct 2022. 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?

Mean change of intraocular pressure (IOP) (time frame: 6 months post initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828057.

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 31 Oct 2022.

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