Our team is highly experienced with Phase I to IV ophthalmic clinical trials.

Our team conduct clinical trials to advance understanding of eye conditions, and how to best treat them. This enables our patients to have timely access to the newest treatments, often before they are broadly available. We are also committed to translating our laboratory-based discoveries into usable technologies, to improve care in clinical practice.

Since 2015, A/Prof Downie has successfully led multidisciplinary teams and supervised staff as Principal Investigator for 16 randomised controlled trials (RCTs), including investigator-initiated studies and pivotal multi-centre trials that have supported international drug regulatory approvals.

Our team is experienced with Phase I to IV clinical trials, including those led by international pharmaceutical and start-up device companies, focusing on novel therapeutics and devices for treating eye disease. We have established research consultancies with several national and international industry partners.

All of our clinical trial staff have current TransCelerate-approved ICH Good Clinical Practice (GCP) certification.

Current projects include prospective RCTs in dry eye disease, corneal neuropathy and contact lens wear.

Recent clinical trial publications

• Britten-Jones AC… Downie LE. Investigating the neuroPRotective effect of Oral Omega-3 Fatty acid Supplementation in type 1 diabetes (nPROOFS1): a randomised, placebo-controlled trial. Diabetes 2021; 70(8): 1794-1806.

This double-masked RCT provided the first robust evidence for oral omega-3 supplementation as a disease-modifying intervention for small nerve fibre health in individuals with type 1 diabetes.

• Downie LE, et al. An Artificial Tear containing Flaxseed Oil for treating Dry Eye Disease: A Randomized Controlled Trial. Ocul Surf 2020; 18:148-57.

The pivotal FDA registration RCT supported the regulatory approval of a new dry eye therapy; the formulation was found to be superior for reducing symptoms compared with standard treatment.

• Deinema LA… Downie LE. A randomized, double-masked trial of two forms of omega-3 supplements for treating dry eye disease. Ophthalmology 2017; 124:43.

This RCT was the first to report the therapeutic efficacy of krill oil for ocular disease, and showed clinical benefit with this form of omega-3 fatty acid supplementation for patients with dry eye disease.

Site overview

  • Our state-of-the-art ophthalmic clinical trial facilities are located in the Department of Optometry and Vision Sciences at the University of Melbourne, 200 Berkeley Street, Carlton, Victoria, Australia.

    Metered on-street parking is available in Berkeley Street and surrounds. Paid, secure parking is also available at the University Square car park.

  • Our facility is equipped with the latest ophthalmic clinical equipment, including specialised infrastructure such as a corneal in vivo confocal microscope and non-contact corneal aesthesiometer.

  • Principal Investigator - A/Prof Laura Downie

    Sub-investigators / Study Coordinators - Ji-hyun (Anna) Lee, Dr Senuri Karunaratne, Dr Sumeer Singh, Eve Makra and Patrick McMillan.