A Study on the 24-hour Intraocular Pressure Profile of the 0.0015% Tafluprost Ophthalmic Solution in Patients with Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma or Ocular Hypertension

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-14004780

Enrollment

Unknown

Registered

2014-06-10

Start date

2014-06-24

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, Ocular Hypertension

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Primary open angle glaucoma, primary angle closure glaucoma or ocular hypertension; 2) Above those who are currently on anti-glaucoma medication (beta-blocker, carbonic anhydrase inhibitor or their combination) and insufficiently controlled; 3) Baseline IOP is 21mmHg or higher (for PACG patient, IOP is to be 21mmHg or higher after laser iridotomy or laser iridoplasty is conducted); 4) Those who can visit the clinic on the designated day as instructed by the physician.

Exclusion criteria

Exclusion criteria: 1) History of intra-ocular surgery (not including laser iridotomy or laser iridoplasty conducted for PACG patients); 2) In case of primary angle closure, laser iridotomy or laser iridoplasty within one month prior to giving the informed consent is conducted; 3) Patients who are treated by prostaglandin analogues or its combinations; 4) 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; 5) Presence of any corneal disorder that may interfere with accurate IOP measurement using applanation tonometry; 6) Presence of corneal disorder that may interfere with accurate 24 hour IOP measurement using contact lens device; 7) Patients who are treated by steroids.(e.g. dexamethasone, hydrocortisone sodium succinate, prednisolone acetate); 8) Female patients who are pregnant, nursing or planning a pregnancy; 9) Patients wearing glasses with metal frames; 10) Patients with severe dry eye syndrome.

Design outcomes

Primary

Measure	Time frame
24-hour IOP variation;	—

Secondary

Measure	Time frame
IOP-lowering effect;	—

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