Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00419

2 Trial Registration Date

2014-06-24

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.283-T

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ms Janice Wong

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

Hong Kong

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

i Name

Dr. Jhanji, Vishal

ii Address

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

iii Phone

39435807

iv Email

vishaljhanji@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

Randomized, Contralateral Eye Study to Evaluate the Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

10 Public Title

Randomized, Contralateral Eye Study to Evaluate the Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

i Public Title in Chinese 研究名稱

青光眼藥物治療用於控制近視LASIK術後回退的功效及安全性隨機對照臨床試驗

11 Short Title (Optional)

Safety and Efficacy of anti-glaucoma treatment for prevention of regression after Myopic LASIK

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?

2014-06-13

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.283-T

14 Medical Condition Being Studied

Refractive error

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

preservative free timolol 0.5% eye drops

iii Dosage form of the intervention

0.5%

iv Dosage of the intervention

0.5%

v Duration of the intervention

started at 1 week after surgery and would be continued up to 3 months postoperatively

vi Frequency of the intervention

Twice daily

16 Comparative Treatments

i Description/ name of comparative treatments

Not Applicable

ii Dosage form of the comparative treatments

Not Applicable

iii Dosage of the comparative treatments

Not Applicable

iv Duration of the comparative treatments

Not Applicable

v Frequency of the comparative treatments

Not Applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Patients with myopia or myopic astigmatism aged 21 years or more
2. Anisometropia < 1 diopter

ii Exclusion Criteria

1. Patients aged < 21 years
2. Patients in which the target refraction is not emmetropia
3. Patients with ocular inflammation, diabetes mellitus, connective tissue disorders
4. Patients who have used retinoid acid or equivalent in the past 6 months
5. Patients with known cardiac disease or bronchial asthma

iii Age Minimum

21 years old

iv Age Maximum

999 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

One randomly chosen eye of each patient would receive preservative free timolol 0.5% eye drops.

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-09

21 Target Sample Size

87

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Spherical equivalent
2. Uncorrected visual acuity (UCVA)

24 Secondary Outcome

1. Change in corneal curvature as observed on the corneal topography
2. Change in corneal thickness on corneal topography
3. Adverse effects associated with the treatment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004839

28 Date of Registration in Primary Registry

2014-06-24

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Trial History Detail on 2015-10-13