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Trial History Detail on 2016-04-08

CUHK_CCT00436

2014-10-24

Prospective

2014.140-T

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

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

Nil

Not Applicable

Ms. Jennifer Tsoi

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

3943 5869

jennifertsoi@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Dr. JHANJI Vishal

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

3943 5807

vishaljhanji@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

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

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

Heparin eye drops for vernal keratoconjunctivitis:

Hong Kong

Yes

2014-08-07

Joint CUHK-NTEC Clinical Research Ethics Committee

2014.140-T

Allergy and conjunctivitis

Drug

HyloPARIN

eye drops

4 times a day

6 weeks

4 times a day

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).

eye drops

4 times a day

6 weeks

4 times a day

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]

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

Age 5 years or older

999

Both Male and Female

Interventional

Randomized

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

Placebo

Double-blind

Parallel

Other

NA

2014-11-07

48

Not Yet Recruiting

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

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.

No

2020-04-15

ChiCTR-IPC-14005386 

2014-10-26

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