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Trial History Detail on 2014-06-09

CUHK_CCT00417

2014-06-09

Prospective

12-001

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 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

對原發性開角型青光眼、 原發性閉角型青光眼、正常眼壓性青光眼或高眼壓病人施用0.0015% 他氟前列素 (Tafluprost) 滴眼液後的不良反應概況的研究

AE Study

Hong Kong

Yes

2013-09-26

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

Drug

0.0015% tafluprost ophthalmic solution with 0.001% BAK

One Month

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) 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


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

18 years of age or above

70 years of age or below

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2014-06-21

20

Not Yet Recruiting

To compare the adverse effect profile of tafluprost to latanoprost.

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

No

2015-06-23


Yes

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