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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

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ClinicalTrials.gov Identifier: NCT04828057
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical (Taiwan) Co., LTD

Study Description
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Brief 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), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

Condition or disease Intervention/treatment
Ocular Surface Disease Primary Open Angle Glaucoma Drug: Tafluprost, timolol maleate

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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Intervention Details:
  • Drug: Tafluprost, timolol maleate
    Patients prescribe PG mono who occurs OSD or I IOP lower insufficient. patients switch to combination therapy.
    Other Names:
    • latanoprost
    • tafluprost
    • bimatoprost
    • travoprost

Outcome Measures
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Primary Outcome Measures :
  1. Mean change of intraocular pressure (IOP) [ Time Frame: 6 months post initiation ]
    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


Secondary Outcome Measures :
  1. Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks [ Time Frame: from baseline to after 4 and 12 weeks of treatment from initiation ]
    Mean change in intra-ocular pressure (IOP) 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 [ Time Frame: 12 weeks post initiation ]
    Proportion of responders at 12 weeks,defined as change from baseline IOP of 20% or more

  3. Evaluation of clinical signs with Tafluprost / Timolol [ Time Frame: 6 months post initiation ]
    o Change in conjunctival hyperaemia distribution by severity

  4. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Dry eye

  5. Evaluation of the effectiveness (IOP-development) of Tafluprost / Timolol by the physician as measured by change in distribution by severity [ Time Frame: 6 months post initiation ]
    • Better than prior medication
    • Same as prior medication
    • Worse than prior medication

  6. Evaluation of clinical signs during therapy with Tafluprost / Timolol by the physician as measured by change in distribution by severity [ Time Frame: 6 months post initiation ]
    • Better than prior medication
    • Same as prior medication
    • Worse than prior medication

  7. Evaluation of tolerability of Tafluprost / Timolol by the Patient as measured by change in distribution by severity [ Time Frame: 6 months post initiation ]
    • Very good
    • Good
    • Satisfactorily
    • Poor

  8. Physician assessment of patient compliance compared to previous therapy [ Time Frame: 6 months post initiation ]
    • Better
    • Equal
    • Worse

  9. Concomitant therapy for glaucoma [ Time Frame: 6 months post initiation ]
    Record concomitant therapy from baseline to 6 months post initiation

  10. Evaluation of clinical signs with Tafluprost / Timolol [ Time Frame: 6 months post initiation ]
    o Change in corneal fluorescein staining (CFS) distribution by severity. Optional

  11. Evaluation of clinical signs with Tafluprost / Timolol [ Time Frame: 6 months post initiation ]
    o Mean change in Visual acuity (VA)

  12. Evaluation of clinical signs with Tafluprost / Timolol [ Time Frame: 6 months post initiation ]
    o Mean change in Schirmer's test. Optional

  13. Evaluation of clinical signs with Tafluprost / Timolol [ Time Frame: 6 months post initiation ]
    o Mean change in tear break up time (TBUT). Optional

  14. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Irritation

  15. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Itching eyes

  16. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Foreign body sensation

  17. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Eye pain

  18. Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe. [ Time Frame: 6 months post initiation ]
    o Other


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828057


Contacts
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Contact: Wei-wen Su +886-975-362-646 vickysuweiwen@gmail.com

Locations
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Taiwan
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital Recruiting
Taoyuan city, Taiwan, 333012
Contact: Su Wei-Wen    +886-975-362-646    vickysuweiwen@gmail.com   
Sponsors and Collaborators
Santen Pharmaceutical (Taiwan) Co., LTD
Investigators
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Principal Investigator: Wei-wen Su Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
More Information
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Responsible Party: Santen Pharmaceutical (Taiwan) Co., LTD
ClinicalTrials.gov Identifier: NCT04828057    
Other Study ID Numbers: TW-VISIONARY Study
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santen Pharmaceutical (Taiwan) Co., LTD:
tafluprost
Tapcom-s
switching
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Travoprost
Latanoprost
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions