Clinical Trials

The Clinical Research and Trials Centre at the Brien Holden Vision Institute was previously known as the International Clinical Trials Centre, which was a research discipline of the Institute for Eye Research. Prior to this, clinical research was conducted by the Institute's predecessor, the Cornea and Contact Lens Research Unit (CCLRU), which was established at the University of New South Wales, Sydney, in 1976. clinic_jenrebecca3

Multidisciplinary Team

Our multidisciplinary team of staff are highly experienced in conducting clinical trials and participate in on-going training throughout their employment to ensure the highest standards of clinical trials conduct are met. Positions include:

Administration/Management

Receptionists
Stock Controller
Practice Manager
Clinical Operations Manager
Head of Clinical Research

Clinical Compliance

Clinical Compliance Manager
Clinical Research Associate

Project Teams

Research Optometrist / Principal Investigator
Clinical Optometrist / Sub-Investigator
Clinical Coordinator

Data Management/Statistics

Biostatisticians
Senior Data Coordinator

Clinical Trials Services

The Clinical Research and Trials Centre offers a full clinical trials service, from concept to end of clinical trial reports, including:

Trial ideas
Trial design
Protocol, Informed Consent and Case Report Form (CRF) design
Internal monitoring
Customised ‘direct data entry’ database production and management
End of clinical trial report writing

Clinical Research Areas

Our research is focused on the following areas:

Development of new contact lens designs and concepts for vision correction
Assessment of new technologies for vision correction
Development of contact lens care solutions
Biocompatibility assessment of contact lenses and contact lens care products
Visual and physiological performance of contact lenses
Clinical evaluation of new contact lens materials and designs
Development of extended and continuous wear lenses
Reduction of ocular inflammation and infection rates with contact lenses
Improving clinical performance and biocompatibility of contact lenses
New ways in controlling myopia progression

Research and Development Achievements

The Brien Holden Vision Institute has designed and conducted research projects leading to the development of several highly successful commercial products.

The Institute collaborated with CIBA VISION in the development of a new highly oxygen permeable breakthrough material, the silicone hydrogel polymer. This is currently commercialised as the CIBA VISION products: the AIR OPTIX™AQUA and AIR OPTIX™ NIGHT & DAY AQUA contact lenses. The invention of the silicone hydrogel contact lens solved the problem of supplying high enough levels of oxygen to the cornea to overcome the problem of hypoxia.

Soft toric contact lenses for the correction of astigmatism. These lenses were developed in collaboration with Ocular Sciences Inc and were successfully launched worldwide in 2002 as the Biomedics Toric lens. The lens is one of the most successful toric designs ever launched.

Multifocal soft contact lens for correction of presbyopia launched by CIBA VISION in February 2009 as the AIR OPTIX™ AQUA MULTIFOCAL contact lenses.

Standards

All Clinical Research and Trials Centre optometrists are highly qualified and are required to demonstrate concordance at regular intervals, and undergo regular training to maintain and enhance general and specialised optometric skills.

Clinical trials are conducted to international clinical trial standards and company standard operating procedures (SOPs). Local and international regulations and guidelines met include:

A commitment to continuous improvement is the key to our ongoing success.

Industry, Sponsors & Collaborators

If you are an industry organisation, a potential sponsor or collaborator and would like to learn more about the Clinical Research and Trials Centre click here.