Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00436

2 Trial Registration Date

2014-10-24

i Registration Status

Prospective

3 Secondary IDs

2014.140-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

Nil

Function

Not Applicable

Please specify

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

i Name

Ms. Jennifer Tsoi

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

3943 5869

iv Email

jennifertsoi@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

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, 3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

iii Phone

3943 5807

iv Email

vishaljhanji@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Efficacy of Heparin eye drops for management of vernal keratoconjunctivitis: Randomized Controlled Trial

10 Public Title

Efficacy of Heparin eye drops for management of vernal keratoconjunctivitis: Randomized Controlled Trial

i Public Title in Chinese 研究名稱

肝素滴眼液對於春季角膜結膜炎的療效的實驗研究：隨機對照試驗

11 Short Title (Optional)

Heparin eye drops for vernal keratoconjunctivitis:

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?

2014-08-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.140-T

14 Medical Condition Being Studied

Allergy and conjunctivitis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

HyloPARIN

iii Dosage form of the intervention

eye drops

iv Dosage of the intervention

4 times a day

v Duration of the intervention

6 weeks

vi Frequency of the intervention

4 times a day

16 Comparative Treatments

i Description/ name of comparative treatments

Heparin eye drops: Heparin eye drops are commercially available as preservative-free Hyloparin eye drops (Ursapharm, Germany). Each 10 ml bottle contains heparin 1300 IU/ml and 1 mg/ml of sodium hylauronate. The eye drops are available in special COMOD system (COMOD: COntinuous MOno Dose), which is an airless application system enabling delivery of multiple sterile doses of eye drops. The eye drops have been approved by the European Medicines Agency (EMA).

ii Dosage form of the comparative treatments

eye drops

iii Dosage of the comparative treatments

4 times a day

iv Duration of the comparative treatments

6 weeks

v Frequency of the comparative treatments

4 times a day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1.Age 5 years or older
2.Diagnosed with bilateral vernal keratoconjunctivitis based on the history and clinical examination
3.Grade 1 (mild, intermittent), grade 2A (moderate, intermittent), grade 2B (moderate, persistent), and grade 3 (severe) VKC [18]

ii Exclusion Criteria

1.Age less than 5 years
2.Grade 4 (very severe), and grade 5 (evolution) VKC [18]
3.Any other active ophthalmic disease
4.Pregnancy or breastfeeding
5.Solid organ transplant recipients
6.Blood disorders
7.Hypersensitivity to heparin or related products

iii Age Minimum

Age 5 years or older

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Both eyes of each patient will be assigned to two arms (group 1: topical heparin eye drops / group 2

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-11-07

21 Target Sample Size

48

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Efficacy of heparin eye drops on the objective signs, and ocular symptoms form the Visual Analog Scale

24 Secondary Outcome

1.Changes in the tear cytokine profile before and after the treatment
2.Visual acuity outcomes
3.Requirement of additional treatment in the form of topical mast cell stabilizers or corticosteroids
4.Complications associated with the treatment and disease per se.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-04-15

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-14005386

28 Date of Registration in Primary Registry

2014-10-26

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Trial History Detail on 2016-04-08