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Trial History Detail on 2015-04-08

CUHK_CCT00418

2014-06-10

Prospective

12-002

Santen Pharmaceutical Co., Ltd.

Santen Pharmaceutical Co., Ltd.

N/A

Miss Wong Sin Ting Janice

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435825

janicewong@cuhk.edu.hk

The Chinese University of Hong Kong

Prof. Tham Chee-yung, Clement

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

3943 5823

clemtham@cuhk.edu.hk

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

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

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

對原發性開角型青光眼、原發性閉角型青光眼或高眼壓病人施用0.0015% Tafluprost(他氟前列素)滴眼液後的24小時眼球內壓概況的研究

24hr study

Hong Kong

Yes

2012-10-19

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

Drug

0.0015% tafluprost ophthalmic solution with 0.001% BAK

Two Months

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).

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

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

18 years of age or above

999

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2014-06-24

15

Recruiting

24-hour IOP variation

IOP-lowering effect

No

2018-04-20

ChiCTR-ONC-14004780 

2014-06-10


Yes

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