Early feasibility and pilot studies for eye devices in New Zealand

A pilot or early feasibility study answers a narrow question quickly: does this device, lens or drop do what we think it does, in real eyes, measured properly? For myopia, contact lens and dry eye products, that first clean dataset often decides whether a larger trial is worth funding. The New Zealand Eye Research Centre (NZERC) in Hamilton focuses on this kind of study.

Why run an early study in New Zealand

• One national ethics system. Health and Disability Ethics Committees (HDECs) review intervention studies for the whole country, so a study does not need separate committee approvals for each institution.
• Published review targets. HDECs aim to reach a final decision within 35 days for applications on the full review pathway and 15 days for the expedited pathway. The clock depends on a complete application and on how quickly questions are answered.
• No IDE prerequisite. A US FDA Investigational Device Exemption is not required before a study starts in New Zealand.
• English-language documentation and clinical standards that overseas regulators are familiar with.

The approval route, step by step

1. Feasibility. We review the protocol outline, population and endpoints and tell you whether the study is achievable at our site.
2. Ethics. An HDEC application is prepared and submitted. Ethics approval applies to interventional trials whether or not they also need approval under the Medicines Act.
3. Medicines. Trials of new medicines need approval under section 30 of the Medicines Act 1981. Medsafe administers these applications, and the Standing Committee on Therapeutic Trials (SCOTT) considers applications for new pharmaceutical-type medicines.
4. Devices. Device studies follow a different route from new medicines. Requirements change, so we confirm the current position with Medsafe for each product before submission.
5. Locality authorisation. Every site needs locality authorisation in addition to HDEC approval before a study can start.
6. Indemnity and compensation. Commercially sponsored trials in New Zealand normally use standardised indemnity and compensation agreements, with the sponsor providing participant injury cover to industry guidelines.

This is a general description, not regulatory advice. We confirm the requirements for each study at the feasibility stage. Primary sources are the Health and Disability Ethics Committees and Medsafe.

What NZERC provides

• Clinician investigators who fit and prescribe the product categories being tested: myopia control lenses, orthokeratology, specialty contact lenses and dry eye devices.
• Access to the relevant patient populations through our affiliated clinical practice, Rose Optometry.
• Repeatable measurement: three optical biometers for axial length, Heidelberg Spectralis OCT, choroidal thickness and choroidal vascularity index, corneal topography and tomography, and a full ocular surface suite. See equipment and endpoints.
• Short-duration designs. Choroidal and axial length measures can show a biological signal within weeks to months, which suits a pilot.

Good candidates for a pilot

• A new myopia control spectacle, contact lens or light-based device that needs first human efficacy and tolerability data.
• A lens material, design or care system that needs comfort, fit and wearing-time data.
• A dry eye device or formulation that needs sign-and-symptom data against a defined control.
• An existing product that needs New Zealand or real-world data to support clinicians.

Talk to us

Email research@nzerc.com with a one-paragraph summary, or use the sponsor enquiry form. More about the site is on our page for sponsors and CROs.