This study aims to determine whether a new treatment, product, or device is safe and effective in improving or stabilising ocular conditions in individuals affected by the specific ocular condition being investigated.

At Ophthalmic Trials Australia (OTA), our focus is on diseases of the anterior segment (more so the ocular surface) of the eye, with Dry Eye Disease (DED) being a primary or secondary component of these conditions. Each clinical trial we conduct has undergone prior preclinical testing (toxicology and safety), including animal studies, and has received rigorous ethical and regulatory (HREC) approval to be conducted in Australia.  Our governance officer, MD’s, OD’s and Ophthalmology team have also carefully screened all aspects before project commencement.

At OTA, the most common Investigational Product (IP) seen is an eye drop. This new drop is not something seen on the market or at least not available in Australia, thus must be put through a rigorous clinical trial phases prior to regulatory approval and ultimately patient access. In some studies, the IP may cause transient local to instillation site stinging/burning sensation that is typically no more than what eye drops you’d use currently to treat your ocular disease. This sensation is often to be expected and is discussed prior to starting the study at the informed consent time point. We have also performed studies involving Investigational Devices (ID) which may be used to cool, heat, stimulate, illuminate or lubricate either the eye or around the eye.

It is, of course, possible that any of these may cause discomfort, and the level of which differs between people (due to varying severities of the disease) and trials (due to the varying treatments).  Each participant is free to withdraw from the study at any time.  Participation is voluntary with adequate time and consideration for participation (including consultation with their medical practitioner, specialist, or significant other) given. 

What tests are done?  Typically, we determine eligibility at a screening visit, then obtain a series of baseline readings. On the first day, prior and post-IP application involves a series of tested parameters. These tests differ from trial to trial, but the most common (for signs) are a slit-lamp assessment, meibomian gland evaluation, subjective/manifest refraction, best corrected visual acuity, tear meniscus height, non-invasive tear break-up time, and a Patient Reported Outcome (PRO) (for symptoms)

All of these will give us and the sponsor data points to analyse the effectiveness of the treatment (often compared to a placebo). It is important to know that being on the trial does not guarantee that you will receive the new treatment. It is entirely possible that you will receive the placebo, which is typically the vehicle for the active IP. Albeit some trials do not have a placebo.  You will be informed of what design of study you are involved in with the disclosure in the patient informed consent. 

The chances you will get the experimental treatment or the placebo changes per trial. Some chances are 1/3, 1/5 or even 100% that you will get both. Most of the time the study is “masked” so neither the principal investigator or you will know what treatment arm you are on. However, at OTA we have an “unmasked” team whose sole job is to know who is on the experimental treatment and who is on the placebo. Their focus is on IP management, acceptance, storage, monitoring, accountability and application. 

If you are worried that your treatments will get worse over the period of the trial either due to the fact that the placebo is less than what you’d usually use to manage your symptoms or that the experimental treatment doesn’t work for you it is our duty to ensure that your symptoms are not disregarded and that the trial is safe. If the placebo is not enough for symptom management, you are free to withdraw at any time. Moreover, if the IP treatment does not work or isn’t enough to manage your symptoms, you may also withdraw from the trial at any stage. Participation is voluntary and a participant may withdraw at any time. 

With every trial there is always the risk that you may not improve or possibly worsen which is why we have closely monitored ocular reviews and questionnaires for symptom monitoring. We also allow and encourage calling at any time if you have an emergency or need of assistance. 

The benefits of course are improved or complete loss of symptoms caused by your ocular disease. This result is our most desired as it not only helps you as a participant but also all those suffering with this disease that will reap the benefits if the experimental treatment proceeds to market. 

The downside is that once the trial is over, you will not be able to continue to use the IP until it is on the market. There are some trials where they allow for participants on Phase I/II to be on Phase II/III, so you may get the chance to be on the treatment again however, not every trial will allow this.  It has also been the case that a protocol has been repeated in a longer format to examine the effects over a longer period of time which creates the opportunity for re-enrollment. 

Through the assessments we run in the clinic, the Investigator and scribe record the results and can have an idea of whether or not the treatment is working through either increased gland function, decreased redness/irritation, increased moisture (etc.).  In a masked design of trial the masked team do not know what treatment a participant is on. Not only through the in-clinic assessments, but you as a participant may be able to tell through a bettering or worsening of symptoms.  You simply report your symptoms as they are at each visit. 

Unfortunately, this isn’t an easy question to answer, as each trial is different in this regard. Some may last for months, others weeks, and some just a single one-off visit. Once you express interest and what type of trial you’d like to be on (i.e., DED, oGVHD, Sjogrens-related DED, COSP…), we will reach out when a trial that suits is approaching and schedule timing/appointments. We have had trials where in-clinic visits last 30min some that last 2- 3 hours, and some where an overnight stay is required. We will communicate with you about trials that suit you both in regard to the experimental treatment and what it’s trying to treat, and the timing/longevity of the appointment and trial.

The study will take place at our clinic by our staff in Suite 2/53 Commercial Rd, Teneriffe, where OTA often shares resources with Mark Hinds Optometrists.  If there is an overnight stay, we join forces with a local research facility that caters to these visits. 

Yes, if required, we may hire what we call a “shuttle service,” which isn’t what it seems, as he is our private driver for OTA in his Tesla, not an actual shuttle bus. However, on trials where he is not needed for most/all the participants, we can organise taxis (or ride share) to pick you up and drop you off. If you are happy to do that yourself, you may be reimbursed.

No, if you decide to participate in a trial with us, your regular doctor will not be able to perform any assessments. However, there may be other sites that will do the same trial.  Our Australian, New Zealand, and Canadian working partners can be seen at the bottom of our page “Our Investigators”.

Depending on the trial, you may need to answer questionnaires in your own time, fill in “study drug accountability diaries” to ensure you’re compliant with dosage, and take eye drops. You will also have visits with us in-clinic, which will be organised before the study.  You will have a very clear list of what is required before committing to the study. 

Your privacy and safety are our number 1 priority. Please see some of the steps below that are taken to protect this:

1. Ethics Committee Oversight
   All clinical trials must be reviewed and approved by a Human Research Ethics Committee (HREC). This independent body ensures that your personal and health information is handled ethically, securely, and confidentially.
2. Informed Consent Process
   Before participating, you will receive a Participant Information Sheet and Consent Form (PICF). This outlines how your data will be used, stored, and shared. You must give written consent before any data is collected, and any tests are conducted.
3. De-Identification of Data
   Your data is typically de-identified—this means in everything but the original source, which is seen by OTA and our monitor (Clinical Research Associate) only, your name and personal identifiers are removed or replaced with a unique code. Researchers analysing the results will not know your identity.
4. Secure Data Storage
   All information is stored in secure, access-controlled systems that meet Australian data protection standards. Only authorised personnel have access to your data.
5. Compliance with Australian Privacy Laws
   Clinical trials in Australia must comply with the Privacy Act 1988 and the Australian Code for the Responsible Conduct of Research. These laws regulate how your personal and health information is collected, used, and disclosed.
6. Sponsor and Regulator Safeguards
   Trial sponsors (e.g., biotech/pharmaceutical companies) and regulators (e.g., the TGA) may audit trial data, but they are also bound by confidentiality and privacy laws.
7. Right to Withdraw
   You can withdraw from a trial at any time, and you may request that your data be no longer used.  Participation is voluntary. 

If you’re participating in a trial through Ophthalmic Trials Australia, rest assured that patient confidentiality is our priority, and all privacy practices align with national standards and international Good Clinical Practice (GCP) guidelines.