Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00628

2 Trial Registration Date

2018-10-19

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

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

3943 5825

iv Email

janicewong@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

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

i Name

Dr. Leung Kai Shun Christopher

ii Address

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

iii Phone

3943 5825

iv Email

cksleung@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Identification of biomarkers for glaucoma in the tear fluid by next generation proteomic technology

10 Public Title

Identification of biomarkers for glaucoma in the tear fluid by next generation proteomic technology

i Public Title in Chinese 研究名稱

利用下一代蛋白質組學技術鑑定淚膜中青光眼的生物標誌物

11 Short Title (Optional)

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?

2018-05-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.065

14 Medical Condition Being Studied

glaucoma

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

A registered optometrist will collect tears sample from newly diagnosed glaucoma patients' both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

iii Dosage form of the intervention

Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

iv Dosage of the intervention

Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

v Duration of the intervention

Around 30 minutes

vi Frequency of the intervention

Once

16 Comparative Treatments

i Description/ name of comparative treatments

A registered optometrist will collect tears sample from normal control's both eyes. The procedure takes around 30 minutes. Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

ii Dosage form of the comparative treatments

Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

iii Dosage of the comparative treatments

Ten to fifteen microliters tear will be obtained from the right lateral canthus of each subject using glass capillary tubes.

iv Duration of the comparative treatments

Around 30 minutes

v Frequency of the comparative treatments

Once

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Control group subject inclusion criteria: 1. Chinese adults aged between 40-60

Control group subject inclusion criteria: 2. Spectacle corrected monocular VA: 0.2 logMAR or better after full correction

Control group subject inclusion criteria: 3. No contact lens wear

Control group subject inclusion criteria: 4. Free of ocular and systemic abnormalities e.g. cataract, diabetes mellitus (DM) Intraocular pressure (IOP): 21 mmHg or less in both eyes

Control group subject inclusion criteria: 5. Difference in IOP between two eyes: 3 mmHg or less

Control group subject inclusion criteria: 6. Able to give written consent

Newly diagnosed glaucoma group subject inclusion criteria: 1. Early onset of signs of primary open-angled glaucoma (POAG)

Newly diagnosed glaucoma group subject inclusion criteria: 2. Intraocular pressure (IOP): 22 mmHg or more in one or both eyes

Newly diagnosed glaucoma group subject inclusion criteria: 3. Sign of optic nerve abnormalities according to the classification of Mild or Early Stage Glaucoma in the Glaucoma ICD-10 quick reference guide of the American Academy of Ophthalmology (AAO)

Newly diagnosed glaucoma group subject inclusion criteria: 4. Free from other ocular and systemic diseases e.g. cataract, DM etc.

Newly diagnosed glaucoma group subject inclusion criteria: 5. Able to give written consent

ii Exclusion Criteria

1. Regular contact lens wear

2. DM, severe heart disease, history of stroke

3. Dry eye disease

4. Underwent LASIK surgery

iii Age Minimum

40

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

4

Please specify

vi Study Objectives (Optional)

To study the differential protein expressions of TGF-β-associated and ECM pathways in the tear fluid of normal control and newly diagnosed glaucoma patients by next generation proteomic approach, High Resolution Multiple Reaction Monitoring (MRM-HR).

20 Anticipated trial start date

2018-11-01

21 Target Sample Size

14 control subjects and 14 subjects with newly diagnosed glaucoma

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Differentially protein expressions

ii The metric or method of measurement used

The total protein concentration will be determined using the 2-D Quant Kit (Amersham Biosciences) according to manufacturer’s instruction.

iii The timepoint(s) of primary interest

one

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-12-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-10-19