Clinical Drug Trial Centre

The CUHK-HKEH Clinical Drug Trial Centre was established to conduct clinical studies in compliance with the guidelines of Good Clinical Practice (GCP) to protect subjects’ right and safety, as well as to ensure the integrity of study data which are credible and accurate. Our Centre is located in Hong Kong Eye Hospital. Since 2006, both Hong Kong Eye Hospital (HKEH) and Joint Shantou International Eye Centre (JSIEC) have been accredited by the National Medical Products Administration (NMPA) as trial centres in ophthalmology. The centre has conducted a number of sponsored clinical trials in different subspecialty; including clinical trials for the purpose of US Food and Drug Administration (FDA) certification.

National Medical Products Administration (NMPA) accreditation (Certificate)

Hong Kong Eye Hospital was accredited by the National Medical Products Administration (NMPA) since 2006. That means the clinical study data generated from our site can be accepted by the NMPA for registration purpose. Our data can also be submitted to US, European and Japanese regulatory authorities.

 

Track Record

With over 15 years of experience, we can provide you with the confidence that your studies will be carried out according to plan. Our dedicated research team have conducted clinical trials on a wide range of therapeutic agents including topical eye drops and drugs delivered into the eye and retina to treat various eye diseases, including glaucoma, macular degeneration, retinal vascular occlusive diseases and pathologic myopia.

  • Over 20 of Clinical Trials Completed
  • Over 200 Patients Recruited
  • 7 Ongoing Clinical Trials

 

Listed of disease types of the ongoing sponsored clinical trials in our centre:

Open Angle Glaucoma

Ocular Hypertension

Neovascular Age-related Macular Degeneration

Diabetic Macular Edema

Central Retinal Vein Occlusion

Patient Area & Consultation

Private consultation rooms Smoke detectors and sprinklers
Treatment room or exam room Private area for conducting patient interviews and informed consent
Centre-wide Wi-Fi connection 24 hours CCTV

 

Study Administration

Secure study file storage area Scanner/Copier/Printer
Telephone and Fax machine with international dialing

 

Drug Storage & Specimen Processing

Refrigerators (2º – 8º C) for drug storage -80°C refrigerators are available for tissue samples storage
Cabinets for drug storage (for ambient temperature drugs) Centrifuge
Secure area for storing laboratory kit supplies Backup generator
Temperature loggers for Investigational Product (IP) refrigerator

 

Study Equipment

Forehead & Oral Thermometer Tono-Pen Tonometer
Digital blood pressure monitor Non-contact Tonometer
Body weight and height scale Ultrasonic Pachymeter
Refraction -Trial Frame & trial lenses Specular microscopy
Auto-refraction by Nidek auto keratorefractor ARK-510A Gonioscopy
BCVA Examination Slit Lamp Biomicroscopy
Goldmann Applanation Tonometer Ophthalmoscope (Indirect)
Digital Color Fundus Photography Contrast sensitivity test (Pelli-Robson)
Spectralis Optical Coherence Tomography Contrast sensitivity test (CSV-1000)
CASIA 2 –Cornea/Anterior Segment OCT Color vision test (Farnsworth D-15 Test)
TOPCON Triton 3D Optical Coherence Tomography Lensmeter (Topcon LM-P6)
Cirrus high-definition optical coherent tomography Ultrasound biometry-A scan (Tomey AL-100)
Fluorescein Angiography IOL Master (Carl Zeiss IOL Master 500)
Indocyanine angiography IOL Master (Carl Zeiss IOL Master 700)
Humphrey Matrix Visual Field Analyzer Visual field analyzer (Carl Zeiss HFA3 860)
Multi-focal electroretinogram Procyon Pupillometer
Potential acuity meter Nidek OPD-Scan III –Refractive power / corneal analyzer
A/B Scan (Tomey UD-1000) Oculus Pentacam AXL System
Heidelberg Retina Tomograph III Oculus Keratograph 5M