Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00417

2 Trial Registration Date

2014-06-09

i Registration Status

Prospective

3 Secondary IDs

12-001

4 Source(s) of Funding

Santen Pharmaceutical Co., Ltd.

5 Primary Sponsor

Santen Pharmaceutical Co., Ltd.

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Miss Wong Sin Ting Janice

ii Address

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

iii Phone

39435825

iv Email

janicewong@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Tham Chee-yung, Clement

ii Address

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

iii Phone

3943 5823

iv Email

clemtham@cuhk.edu.hk

v Affiliation

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

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

AE Study

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-09-26

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

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

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

0.0015% tafluprost ophthalmic solution with 0.001% BAK

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

One Month

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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).

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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

ii 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

iii Age Minimum

18 years of age or above

iv Age Maximum

70 years of age or below

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-06-21

21 Target Sample Size

20

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

To compare the adverse effect profile of tafluprost to latanoprost.

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-06-23

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-06-09