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A Study on the Adverse Effect Profile of the 0.0015% Tafluprost Ophthalmic Solution in Patients with Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Normal Tension Glaucoma or Ocular Hypertension

A Study on the Adverse Effect Profile of the 0.0015% Tafluprost Ophthalmic Solution in Patients with Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Normal Tension Glaucoma or Ocular Hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-14004779
Enrollment
Unknown
Registered
2014-06-10
Start date
2014-06-21
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Normal Tension Glaucoma, Ocular Hypertension

Interventions

one cohort:Colorless clear 0.0015% aqueous ophthalmic solution containing 15 ug of tafluprost in 1 ml One drop is instilled to the affected eye(s), once daily (same as the approved dosage) for one mon

Sponsors

Santen Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with primary open angle glaucoma (POAG), primary angle closure glaucoma (PACG), normal tension glaucoma (NTG) or ocular hypertension (OHT); 2) Switching from latanoprost (other concomitant drugs should not be changed 1 month prior to the switch of medication and are continued during the treatment period); 3) Age between 18 to 70 years; 4) Those who can visit the clinic on the designated day as instructed by the physician.

Exclusion criteria

Exclusion criteria: 1) History of intraocular surgery or laser treatment during the three months before informed consent; 2) History of corneal refractive surgery; 3) 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 investigational product; 4) Presence of any corneal disorder that may interfere with accurate IOP measurement using applanation tonometer; 5) Female patients who are pregnant, nursing or planning a pregnancy; 6) Patients who need to change their pretreating ophthalmic medications (other than latanoprost) during the study.

Design outcomes

Primary

MeasureTime frame
To compare the adverse effect profile of tafluprost to latanoprost;

Secondary

MeasureTime frame
To compare the IOP - lowering effect of tafluprost to latanoprost.;

Countries

China

Contacts

Public ContactProf. Tham Chee-yung, Clement
clemtham@cuhk.edu.hk+852 3943 5823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026