Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00039

2 Trial Registration Date

2005-09-08

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

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

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

FAN Shu Ping Dorothy

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

vi Country

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

i Name

FAN Shu Ping Dorothy

ii Address

iii Phone

27623168

iv Email

telephone

v Affiliation

vi Country

9 Official Scientific Title of the Study

Randomized Trial to Investigate the Ocular Hypertensive & Anti-inflammatory Response to 0.5% Lotemax & 1% Fluorometholone in Chinese Children

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2002-04-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Eye Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

0.5% Lotemax

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

0.1% fluorometholone

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

Inclusion criteria: children age 2 to 12 Children receive bilateral strabismus operation Exclusion criteria history of ocular hypertension or glaucoma eye diseases other than strabismus and refractive error family history of glaucoma application of steriod in the past 1 year

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2005-05-01

21 Target Sample Size

70

22 Recruitment Status

Recruiting

23 Primary Outcome

Intraocular pressure

24 Secondary Outcome

Inflammation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-12-04

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

None

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Trial History Detail on 2005-09-08