RecruitingPHASE3INTERVENTIONAL

Parasitic Ulcer Treatment Trial

This important study, called the Parasitic Ulcer Treatment Trial (PUTT), is looking for people in the UK with a specific eye infection called Acanthamoeba Keratitis. This infection causes sore eyes and can sometimes affect contact lens users. Researchers want to find out if adding a steroid medication to the usual treatment helps improve eyesight. If you have this infection and your eye is still inflamed after a month of existing treatment, you might be able to join. You'd be randomly assigned to receive either the steroid eye drops or a dummy (placebo) eye drop. This study aims to help doctors understand the best way to treat this condition and improve outcomes for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Jeremy Keenan, MD, MPH

Enrolment target

232

Start

01 Jul 2024

Estimated completion

01 Jul 2029

Acanthamoeba Keratitis

What is this study about?

This study is called the Parasitic Ulcer Treatment Trial (PUTT). It's designed to help doctors understand the best way to treat a specific eye infection called Acanthamoeba Keratitis (AK). This infection can be serious and sometimes affects people who wear contact lenses. If you have this infection, it can cause inflammation and affect your vision.

Currently, there's a standard treatment for AK. However, even after a month of this treatment, some people still have inflammation in their eye. Researchers want to know if adding a type of medication called a corticosteroid (often just called a steroid) to the existing treatment can help improve a patient's vision more than the standard treatment alone. Steroids are known to reduce inflammation, but doctors need to confirm if they are helpful, or perhaps even harmful, for this particular eye condition.

To find this out, the study will involve volunteers who have AK and still have inflammation after a month of their usual anti-amoebic treatment. Participants will be split into two groups by chance: one group will receive steroid eye drops, and the other will receive a placebo (dummy) eye drop that looks the same but contains no active medicine. This way, researchers can compare the two approaches fairly and determine if adding steroids makes a real difference to eyesight.

Key takeaways

This study investigates adding steroids to treatment for a serious eye infection (Acanthamoeba Keratitis).
It aims to see if steroids improve vision for those still inflamed after a month of standard treatment.
Participants will be randomly assigned to receive either steroid eye drops or a dummy (placebo) treatment.
Regular clinic visits will be needed to monitor your eye and treatment progress.
Your willingness to participate can help improve future treatments for this condition.

Who may be eligible?

To join this study, you would need to have been diagnosed with Acanthamoeba Keratitis (AK) in at least one eye. This diagnosis must be confirmed by tests like a swab, special scan, or biopsy. It's also important that your eye is still showing signs of inflammation (like redness or irritation) after you've been on your standard AK treatment for about a month.

There are also some reasons why you wouldn't be able to join. For example, if you have a history of certain other eye conditions like specific types of keratitis (e.g., fungal or herpes), or if your eye is very severely damaged (like a tear or a hole). You also wouldn't be able to take part if you've had a specific type of eye surgery for AK before, or if you can't see any light at all with your affected eye. Anyone allergic to steroids or taking other steroid medications in their body would also not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with Acanthamoeba Keratitis.
My eye is still inflamed after about a month of anti-amoebic treatment.
I do not have other serious eye conditions like certain fungal or herpes infections.
I am not allergic to steroids and not currently taking other systemic steroid medications.
I can attend regular clinic appointments for monitoring.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a number of checks to make sure you're suitable. Once confirmed, you'll be randomly assigned to one of two treatment groups: you'll either receive eye drops containing a steroid, or eye drops that are a placebo (a dummy treatment). You won't know which one you are getting, and neither will your doctors, to keep the study fair. You'll continue with your usual anti-amoebic treatment during this time.

You will have regular visits to the clinic so doctors can monitor your eye condition, check your vision, and assess any side effects. They'll also make sure you're taking your eye drops correctly. The study will involve several appointments over a period of time, though the exact number and duration of these visits aren't detailed here. You should ask your doctor about the full schedule before you decide to join.

Potential risks and benefits

Taking part in this study may offer a potential benefit if the steroid eye drops prove to be effective in improving your vision compared to the standard treatment. However, there's also the chance you might receive the placebo. As with any medication, there could be potential side effects from the steroid eye drops, which your doctor will explain in full detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
University of Colorado Anschutz
Verified postcode
Aurora, United States· Recruiting
University of Florida
Verified postcode
Gainesville, United States· Recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
University of Illinois, Chicago
Verified postcode
Chicago, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
Johns Hopkins University
Verified postcode
Baltimore, United States· Recruiting
Columbia University
Verified postcode
New York, United States· Recruiting
Oregon Health and Science University
Verified postcode
Portland, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
University of Pittsburgh Medical Center
Verified postcode
Pittsburgh, United States· Recruiting
Baylor College of Medicine
Verified postcode
Houston, United States· Recruiting

Common questions

What is Acanthamoeba Keratitis (AK)?

AK is a rare but serious eye infection, often affecting contact lens wearers, that causes painful inflammation and can affect vision.

What are corticosteroids?

Corticosteroids are medications that reduce inflammation. This study wants to see if adding them to AK treatment helps improve vision.

What does 'randomised' mean?

It means you'll be assigned to a treatment group (steroid eye drops or dummy eye drops) by chance, like flipping a coin, to ensure fairness.

Will I know if I'm getting the steroid or the placebo?

No, neither you nor your doctors will know which treatment you are receiving during the study, which is a common practice in clinical trials.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time without needing to give a reason, and your medical care will not be affected.

How to find out more

Jeremy Keenan, MD, MPH

jeremy.keenan@ucsf.edu 415-476-6323 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.