Dry Eye and Autoimmune Condition Study
This study aims to test the safety and therapeutic effect of a potential new treatment (eye drop suspension) in people with autoimmune conditions who are suffering from dry eyes.
Eligibility
- 18 to 85 years of age
- Have had ongoing dry eyes for at least 6 months
- Have been using artificial tears (e.g., lubricating eye drops) at least 2 times per day for at least 30 days
- Have a history of systemic inflammatory autoimmune disease
- Are able to attend clinic visits as required
Location
- NSW
- QLD
- VIC
Duration
- Approximately 3 months (for each participant)
Study Guide
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Who can take part in this study?
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To take part in this study, you will need to meet all the following (other criteria apply):
- Aged between 18 and 85 years (inclusive)
- Have had ongoing dry eyes for at least 6 months
- Have been using artificial tears (e.g., lubricating eye drops) at least 2 times per day for at least 30 days
- Have a history of systemic inflammatory autoimmune disease including (but not limited to):
- Sjogren’s disease
- Lupus
- Chronic osteoarthritis
- Atopic dermatitis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Scleroderma
- Hashimoto’s thyroiditis
- Crohn’s disease
- Able to attend clinic visits at the closest site as required
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Who is unable to take part in this study?
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Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- History of uncontrolled glaucoma or are being treated for glaucoma
- Anticipated use of contact lenses during the 12-week study period.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Unable to make the visits to the clinic as required
Please note, additional eligibility criteria applies.
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What is the purpose of this study?
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This study aims to evaluate the safety and efficacy of a potential new eye drop treatment in people with autoimmune conditions and dry eyes compared to a version of the study medication that has no active ingredient (we call this the “vehicle”).
The potential new treatment has been designed to treat eye inflammation which is associated with dry eyes.
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How many clinic visits will there be?
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If you are eligible for the study, your participation is expected to include 6 visits over the course of approximately 12 weeks.
Please note, participation in this research is voluntary, and you may withdraw from the study at any time, for any reason. Leaving the study will have no impact on your regular medical care.
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What are Dry Eyes?
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Dry Eye is a common condition that occurs when tears don’t adequately lubricate the eyes, leading to pain, irritation and vision problems. It's often caused by inflammation and can be triggered by various factors, including autoimmune conditions. Symptoms include eye redness, blurry vision, and a burning sensation in the eyes.
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Why is this study important?
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This study is important because dry eyes can negatively impact a person’s sleep quality, professional performance, and overall well-being. While there are currently a number of treatment options for dry eyes including artificial tears, there is still a need for safer and more effective treatments.
The findings from this study could lead to improved relief from the persistent and debilitating symptoms of dry eyes.
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Who is sponsoring this study?
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Iolyx Australia Ltd Pty (Iolyx) is the sponsor of this study. Iolyx is a pharmaceutical company focused on transforming the standard of care for ocular disease at the intersection of immunology and ophthalmology.
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Where is my nearest study site?
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Here is a list of the sites who are conducting this study:
NSW
- University of New South Wales, Kensington
- Sydney Eye Hospital, Sydney
QLD
- Queensland University of Technology, Brisbane
SA
- Innovative Eye Care, Adelaide
VIC
- University of Melbourne, Carlton
- Deakin University, Waurn Ponds
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What if I have other questions about the study?
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