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

NCT04828057 | Completed

• 1 other identifier: TW-VISIONARY Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Surface Disease; Primary Open Angle Glaucoma

Keywords

tafluprost; Tapcom-s; switching

Outcome Measures

Primary Outcomes (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

  6 months post initiation

Secondary Outcomes (18)

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

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

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

  12 weeks post initiation

• Evaluation of clinical signs with Tafluprost / Timolol

  6 months post initiation

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

  6 months post initiation

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

  6 months post initiation

Interventions

Tafluprost, timolol maleate DRUG

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

Also known as: latanoprost, tafluprost, bimatoprost, travoprost

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Pharmaceutical (Taiwan) Co., LTD: lead

Study Sites (1)

Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Taoyuan, 333012, Taiwan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

tafluprost; Timolol; Latanoprost; Bimatoprost; Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Cloprostenol

Study Officials

• Wei-wen Su

  Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

TW (1)