What We Do & Recent Publications

ARVO 2026 – Denver – Colorado – May 2026

The Association for Vision and Research in Ophthalmology – Salt Lake City – May 2025

The British Contact Lens Association – Birmingham, UK – 2025

The Association for Vision and Research in Ophthalmology – Seattle – May 2024

Tear Film and Ocular Surface (TFOS) – Venice Italy – October / November 2024

Our Collaborations and Expertise

At Ophthalmic Trials Australia (OTA), we collaborate with leading universities and institutions across Australia, New Zealand, and Canada to support a diverse range of partners, from small biotech startups to large pharmaceutical companies.  Sponsors are from around the globe, with the vast majority originating in the USA. Together, we work to raise awareness of advances in solutions for ocular diseases and drive the development of innovative treatments. Through these strong partnerships, we have had the privilege of contributing to numerous peer-reviewed scientific journals, posters, and podium presentations. Some of our published work is referenced below.

Commitment to Rigorous and Ethical Research

Conducting clinical trials requires meticulous assessment and rigorous oversight. Our research is guided by both external Human Research Ethics Committees (HREC) and robust internal governance frameworks, ensuring that all studies are conducted ethically, safely, and with scientific integrity.  Our team of ODs, MDs, Specialists, and allied health professionals screens all potential clinical trials to ensure not only a safe clinical trial but one that is effective in our search for solutions for unmet needs. 

Comprehensive Clinical Trial Experience

OTA has extensive experience in both therapeutic and device clinical trials, spanning all phases of development—from first-in-human (Phase I) through to post-market assessment (Phase IV). We partner with sponsors to develop first-in-human sentinel dosing protocols, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, and safety committee reporting structures. These processes not only identify safety signals but also provide critical insights into efficacy and Mechanism of Action (MOA).  

State-of-the-Art Facilities and Efficient Trial Delivery

Our easily accessible, custom-built facilities and cutting-edge equipment enable us to conduct safe and timely research. We deeply respect our sponsors’ investment by delivering safe, ethical, unbiased, and efficient resultsWhere possible, all testing facilities have redundancy plans with duplicate or triplicate units.  Moreover, our pharmacy is equipped with a backup battery power and a secondary generator on site. 

Unlike larger organisations such as universities or hospital research settings, OTA benefits from a streamlined management structure. This allows us to expedite trial processes with faster response and turnover times, limited only by external factors beyond our control.  This resource-saving advantage of being faster to terminate or faster to finish is one of our advantages. 

Sponsor Consultancy and Early-Phase Expertise

At OTA, our experienced team provides specialised consultancy services to biotech and pharmaceutical companies, focusing on Phase I (first-in-human) and Phase II clinical trial development for investigational products (IP) and devices. We expertly navigate regulatory pathways and optimise trial logistics to streamline HREC submissions, ensuring efficient, ethical trial execution in full compliance with Good Clinical Practice (GCP). Our deep expertise in early-phase ophthalmic research helps accelerate sponsors’ IP journey from first-in-human studies to proof of concept with early signal identification. 

At OTA, we are proud to have played a key role in pivotal clinical trials that have supported New Drug Applications (NDAs) with the U.S. Food and Drug Administration (FDA). Our contribution to these global programs reflects not only the quality and reliability of our clinical research, but also the strength of Australia as a destination for world-class ophthalmic trials.

By consistently delivering high-quality data, efficient patient recruitment, and strict adherence to international regulatory standards, OTA has been trusted as a partner in trials that directly shaped the evidence base for FDA approval of novel therapies. These therapies now represent new treatment options for patients worldwide—advancing care in areas such as ocular surface disease, retinal conditions, glaucoma, and myopia management.

Our reputation as a leading early- and mid-phase ophthalmic research site ensures that sponsors and CROs look to Australia not just for speed and cost-effectiveness, but for excellence in trial conduct. Each successful NDA we have contributed to reinforces our mission: bringing innovative, sight-saving treatments from the research stage to clinical reality.

Recent Publications & Conference Presentations

At Ophthalmic Trials Australia, we are committed to advancing the future of eye care through high-quality ophthalmic clinical research.

Our team collaborates with leading pharmaceutical companies, biotechnology organisations, universities, ophthalmologists, optometrists, and clinician-scientists across Australia and internationally to help develop innovative therapies and technologies for ocular surface disease, dry eye disease, meibomian gland dysfunction, contact lens discomfort, ocular pain, keratoconus, and other vision-threatening conditions.

OTA investigators and collaborators regularly contribute to:

  • Peer-reviewed scientific publications
  • International ophthalmic conferences
  • Translational ocular surface research
  • Clinical trial innovation and therapeutic development

Our research has been presented at major international meetings including:

  • ARVO (Association for Research in Vision and Ophthalmology)
  • TFOS (Tear Film & Ocular Surface Society)
  • ICCLC (International Cornea and Contact Lens Congress)
  • AAO (American Academy of Ophthalmology)
  • AAOPT (American Academy of Optometry)
  • ASCRS (American Society of Cataract and Refractive Surgery)
  • ISCLR (International Society for Contact Lens Research)

Through these collaborations, Ophthalmic Trials Australia continues searching for better treatment options for people living with eye disease — helping shape the next generation of ophthalmic care.


Featured Research Highlights

ARVO 2026 — Denver, Colorado, USA

Association for Research in Vision and Ophthalmology Annual Meeting
3–7 May 2026

Lid Telangiectasia Following Treatment With AZR-MD-001 0.5% vs Vehicle in Contact Lens Wearers With Meibomian Gland Dysfunction and Dry Eye: The ARIES Phase 2b Study

Authors & Collaborating Institutions
Fiona Stapleton — School of Optometry and Vision Science, UNSW Sydney, NSW, Australia
Jacqueline Tan — School of Optometry and Vision Science, UNSW Sydney, NSW, Australia
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Yair Alster — Azura Ophthalmics Ltd., Tel Aviv, Israel
Charles Bosworth — Azura Ophthalmics Ltd., Tel Aviv, Israel


Improved Corneal Sensitivity After Treatment With a Novel Topical Ophthalmic Cooling Device in Patients With Chronic Ocular Surface Pain

Authors & Collaborating Institutions
Cristos Ifantides — Tyson Eye, FL, USA; University of Colorado Anschutz Medical Campus School of Medicine, Aurora, CO, USA
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Thanh Nguyen — University of Sydney School of Life and Environmental Sciences, Sydney, NSW, Australia
Christopher Rapuano — Wills Eye Hospital, Philadelphia, PA, USA
Axel Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Georgia Duhig — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Ally Stevens — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Chameen Samarawickrama — University of Sydney, NSW, Australia
Bonnie Henderson — HelpMeSee, NJ, USA
Helen Wu — Newton Wellesley Eye, MA, USA
Preeya Gupta — Triangle Eye Consultants, NC, USA
Anat Galor — Bascom Palmer Eye Institute, University of Miami, FL, USA


A Phase I Prospective Open-Label Study Assessing the Safety & Efficacy of rhPRG4 (450 µg/mL Recombinant Human Proteoglycan 4) for the Treatment of Ocular Graft-Versus-Host Disease

Authors & Collaborating Institutions
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Ben Sullivan — Lµbris BioPharma, USA
Tracey Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Axel Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Georgia Duhig — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Brendan Cronin — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Victor Perez — University of Miami, FL, USA
Richard Chang — Lµbris BioPharma, USA
Edward Truitt III — Lµbris BioPharma, USA
Harry Barnett — Lµbris BioPharma, USA
Tannin Schmidt — UConn Health, CT, USA
Gregory Jay — Brown University, RI, USA
David Sullivan — Tear Film & Ocular Surface Society (TFOS), USA
Stephanie Watson — University of Sydney, NSW, Australia


Selected Peer-Reviewed Publications

Ophthalmol Ther — May 2026

A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain

Authors & Collaborating Institutions
Anat Galor — Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA
Christopher Rapuano — Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Alice Epitropoulos — Ophthalmic Surgeons & Consultants of Ohio, Columbus, OH, USA
Jayne Weiss — Louisiana State University, New Orleans, LA, USA
Stephen Pflugfelder — Baylor College of Medicine, Houston, TX, USA
Preeya Gupta — Triangle Eye Consultants, Raleigh, NC, USA
Deepinder Dhaliwal — University of Pittsburgh, Pittsburgh, PA, USA
Laura Periman — Periman Eye Institute, Seattle, WA, USA
Bonnie An Henderson — HelpMeSee, Jersey City, NJ, USA
Thanh T. Nguyen — Save Sight Institute, University of Sydney, NSW, Australia
Chameen Samarawickrama — Save Sight Institute, University of Sydney, NSW, Australia
Helen Wu — Newton Wellesley Eye Associates, Wellesley, MA, USA
Tomasz Stryjewski — Tallman Eye Associates, Andover, MA, USA
James A. Stefater — Ophthalmic Consultants of Boston, Boston, MA, USA
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Pooja Bhindi — Clinical Research Collaborator
Cristos Ifantides — Ophthalmologist and Ocular Surface Researcher

The Ocular Surface — January 2025

Efficacy and Safety of AZR-MD-001 Selenium Sulfide Ophthalmic Ointment in Adults With Meibomian Gland Dysfunction Over Six Months of Treatment: A Phase 2, Vehicle-Controlled, Randomized Extension Trial

Authors & Collaborating Institutions
Laura E. Downie — University of Melbourne, VIC, Australia
Jennifer P. Craig — University of Auckland, New Zealand
Fiona Stapleton — UNSW Sydney, NSW, Australia
Jacqueline Tan — UNSW Sydney, NSW, Australia
Lyndon W. Jones — University of Waterloo, Canada
Alison Ng — University of Melbourne, VIC, Australia
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Charles Bosworth — Azura Ophthalmics Ltd., Israel
Yair Alster — Azura Ophthalmics Ltd., Israel


The Ocular Surface — July 2023

Efficacy and Safety of AZR-MD-001 Selenium Sulfide Ophthalmic Ointment in Adults With Meibomian Gland Dysfunction: A Vehicle-Controlled, Randomized Clinical Trial

Authors & Collaborating Institutions
Stephanie L. Watson — University of Sydney, NSW, Australia
Lyndon W. Jones — University of Waterloo, Canada
Fiona Stapleton — UNSW Sydney, NSW, Australia
Mark Hinds — Ophthalmic Trials Australia, Brisbane, QLD, Australia
Alison Ng — University of Melbourne, VIC, Australia
Jacqueline Tan — UNSW Sydney, NSW, Australia
Yair Alster — Azura Ophthalmics Ltd., Israel
Charles Bosworth — Azura Ophthalmics Ltd., Israel
Omer Rafaeli — Azura Ophthalmics Ltd., Israel
Venita DePuy — Azura Ophthalmics Ltd., USA
The CELESTIAL Study Group


Recent Publication & Presentation List

2026

ARVO 2026 — Denver, Colorado, USA

  • Lid Telangiectasia Following Treatment With AZR-MD-001 0.5% vs Vehicle in Contact Lens Wearers With Meibomian Gland Dysfunction and Dry Eye
    Authors: Fiona Stapleton, Jacqueline Tan, Mark Hinds, Yair Alster, Charles Bosworth
    Institutions: UNSW Sydney, Ophthalmic Trials Australia, Azura Ophthalmics Ltd.
  • Improved Corneal Sensitivity After Treatment With a Novel Topical Ophthalmic Cooling Device in Patients With Chronic Ocular Surface Pain
    Authors: Cristos Ifantides, Mark Hinds, Thanh Nguyen, Christopher Rapuano, Axel Hinds, Georgia Duhig, Ally Stevens, Chameen Samarawickrama, Bonnie Henderson, Helen Wu, Preeya Gupta, Anat Galor
    Institutions: Tyson Eye, University of Colorado, Ophthalmic Trials Australia, University of Sydney, Wills Eye Hospital, HelpMeSee, Newton Wellesley Eye, Triangle Eye Consultants, Bascom Palmer Eye Institute
  • A Phase I Prospective Open-Label Study Assessing the Safety & Efficacy of rhPRG4 for the Treatment of Ocular Graft-Versus-Host Disease
    Authors: Mark Hinds, Ben Sullivan, Tracey Hinds, Axel Hinds, Georgia Duhig, Brendan Cronin, Victor Perez, Richard Chang, Edward Truitt III, Harry Barnett, Tannin Schmidt, Gregory Jay, David Sullivan, Stephanie Watson
    Institutions: Ophthalmic Trials Australia, Lµbris BioPharma, University of Miami, UConn Health, Brown University, TFOS, University of Sydney

Review of Optometry — December 2025

  • Frayed Nerves
    Authors: Kaleb Abbott, Mark Hinds, Paul Karpecki

2025

Healio / Primary Care Optometry News — June 2025

  • ILYX-002 rapidly improves immune-mediated dry eye disease in Phase 2 trial
    Institutional collaboration: Iolyx Australia Pty Ltd and Ophthalmic Trials Australia

ARVO 2025 — Salt Lake City, Utah, USA

  • Phase 2 Trial Results of Topically Administered ILYX-002, a Novel Immune Modulator for Inflammatory Dry Eye Disease
    Authors: Mark Hinds, Houman Hemmati, Elizabeth Jeffers, Erin Newman
  • Water Intake Causes a Measurable Increase in Tear Volume 30 Minutes After Consumption
    Authors: Katie Edwards, Mark Hinds, Binita Ban, Meagan Huxtable, Madeleine Kavur, Farah Najeeb, Louise Verschaeren, Luisa H. Colorado

The Ocular Surface — January 2025

  • Efficacy and Safety of AZR-MD-001 Selenium Sulfide Ophthalmic Ointment in Adults With Meibomian Gland Dysfunction Over Six Months of Treatment

2024

TFOS 2024 — Venice, Italy

  • The Effect of AZR-MD-001 0.5% Ophthalmic Ointment on Meibomian Gland Secretion, Quality and Comfortable Lens Wear Over 3 Months of Dosing in Patients With Contact Lens Discomfort
    Authors: Fiona Stapleton, Jacqueline Tan, Mark Hinds, Yair Alster, Charles Bosworth
  • Inflammatory Dry-Eye Disease: An Ongoing Phase 2 Trial of ILYX-002
    Authors: Fiona Stapleton, Houman Hemmati, Erin Newman

ICCLC 2024 — Gold Coast, Australia

  • AZR-MD-001 Opens Meibomian Glands, Improves Meibum and Tear Quality Resulting in Increased Wear Time and Desired Lens Use in Patients With Contact Lens Discomfort
    Authors: Mark Hinds, Fiona Stapleton, Jacqueline Tan, Yair Alster, Charles Bosworth
  • Efficacy in Resolving the Signs and Associated Symptoms of Contact Lens Discomfort in a Phase 2 Trial
    Authors: Mark Hinds, Fiona Stapleton, Jacqueline Tan, Yair Alster, Charles Bosworth

ARVO 2024 — Seattle, Washington, USA

Multiple presentations involving collaborations between Ophthalmic Trials Australia, Azura Ophthalmics, UNSW Sydney, University of Melbourne, University of Waterloo, and international ocular surface investigators.


2023

ASCRS 2023

  • AZR-MD-001 Efficacy in Resolving the Signs and Associated Symptoms of Meibomian Gland Dysfunction: Phase 2 Responder Status
    Authors: Lisa M. Nijm, Jennifer P. Craig, Mark Hinds, Yair Alster, Charles Bosworth
  • AZR-MD-001 Efficacy in Restoring Gland Function and Improving Signs and Ocular Symptoms of Meibomian Gland Dysfunction
    Authors: Preeya K. Gupta, Laura E. Downie, Mark Hinds, Yair Alster, Charles Bosworth

AAOPT 2023

  • Safety and Efficacy of Topical AZR-MD-001 for the Treatment of Meibomian Gland Dysfunction
    Authors: Fiona Stapleton, Laura E. Downie, Mark Hinds, Yair Alster, Charles Bosworth
  • Sign and Symptom Improvement Rates Among MGD Patients Following 6 Months of Treatment With AZR-MD-001
    Authors: Lyndon W. Jones, Jennifer P. Craig, Mark Hinds, Yair Alster, Charles Bosworth, Alison Ng

AAO 2023

  • Resolution of Signs and Symptoms of Meibomian Gland Dysfunction Following 6 Months of AZR-MD-001 Treatment vs Vehicle
    Authors: Joshua C. Teichman, Lisa M. Nijm, Jennifer P. Craig, Mark Hinds, Yair Alster, Charles Bosworth

ARVO 2023

AZR-MD-001 restores gland function and improves signs and ocular symptoms of meibomian gland dysfunction
Authors: Preeya K. Gupta, Laura E. Downie, Mark Hinds, Yair Alster, Charles Bosworth

AZR-MD-001 efficacy in resolving the signs and associated symptoms of meibomian gland dysfunction in a Phase 2 trial
Authors: Lisa M. Nijm, Jennifer P. Craig, Mark Hinds, Yair Alster, Charles Bosworth