Does lifitegrast improve dry eye symptoms for contact lens wearers?

A recent study found that lifitegrast helps improve symptoms of discomfort and dryness in symptomatic contact lens wearers. Marc-Matthias Schulze, PhD, Dipl Ing, worked alongside Sarah Guthrie, PhD, MSc, Jill Woods, MSc, MCOptom, and Lyndon Jones, DSc, PhD, FRSC, FCAH, on the study and presented their poster on its findings during the American Academy of Optometry meeting in Indianpolis, Indiana.

Video transcript:

Editor's note: The below transcript has been lightly edited for clarity.

Emily Kaiser Maharjan:

Hi everyone. I'm here with Dr Schulze to answer the question of whether or not lifitegrast will improve the symptoms of discomfort and dryness in symptomatic contact lens wearers. So thanks for being here, Dr Schulze.

Marc-Matthias Schulze, PhD, Dipl Ing:

Thanks very much for having me. Very exciting to be part of this.

Kaiser Maharjan:

Of course. So first, can you tell me about the results of the study?

Schulze:

Happy to do so. So what we did in the study was, basically, we tried to find out whether the known benefits of lifitegrast are as applicable to chronic lens wearers. So what we did is we invited participants who report end of day dryness with their chronic lens wear. The typical thing where participants come or patients come into the practice saying, "I can't wear my lenses for long enough, or during the work day, I cannot wear them all day. I'd like to be able to wear something longer." So these are the ones that have probably tried wearing different types of lenses, have tried over the counter medications, eye drops, have tried other things and are still not quite happy. They wear them because they don't like wearing glasses, or for their work they need contacts, but they're not super happy with them.

So we basically asked them whether they had a specific level of end of day dryness, which was a level of 40 on a 0 to 100 rating scale. If it was the case, they would have been eligible if they also reported that they experienced dryness sometimes, and also whether the dryness was on a specific severity level during the regular day. Participants were then basically asked to use their own lenses and solutions. So they continued in on with whatever they were using, with the exception that they were not allowed to use their own artificial eye drops, teardrops, any rewetting drops. They had to stop using those during the study. So basically the idea was, let's keep everything the same, introduce Xiidra or lifitegrast and see what happens.

Participants, if they were eligible, were then dispensed and had to return after 2 weeks, 6 weeks, and 12 weeks. So they were basically in the study for 12 weeks, and at each of those follow up visits, and also before they received the drops the first time, we basically measured their visual analog scale ratings again. So they rated various components, including dryness and discomfort. They completed a CLDEQ-8, and we took the typical clinical measurements you would do for safety. So when they initially came in, we did have 40 participants in total. Typical distribution between females and males,we had about 33 females, 7 males. Fairly wide range, 18 to 66 years of age. I think it's a crucial point: we did have 17 different lens types out of the 40 participants, so fairly big number of lenses. So basically, that tells us it's not going to work for just 1 lens type or 2. It works for a wide variety of lenses. About two thirds are daily disposable errors, and one third was reusable various so a fairly good distribution of the population, I think.

Looking at the results when we started, dryness ratings were around the 76 on the 0 to 100 rating scale, so fairly high levels of dryness. CLDEQ-8 scores were 22 on the 1 to 37 scale. So also in the moderate to severe levels of dryness range for that questionnaire. And after 2 weeks, the participants came back, we already had significant improvements, just after two weeks. So participants reported levels of dryness of 43 instead of 76, CLDEQ-8 eight was 16 after 2 weeks. And to put it in perspective, the CLDEQ-8 was developed, a change of 3 was required for being a significant difference. So that's happened after 2 weeks already, twice as much. Improvements occurred while the partcicipants were going on. So after 12 weeks, typical median ratings were 15 for dryness out of the 0 to 100, so improvement by 60 points. Discomfort, the same idea, improvement by 59 points. And CLDEQ-8 went down to 11 as well. So a lot of improvement with the use of the lifitegrast.

Another thing which is probably worth mentioning is that we did measure wear time with the lenses, obviously. We wanted to know, how long are you wearing the lenses. Participants, when they came into study, they had to have a minimum of 6 hours. The majority was them much longer. So we wear at around 12 hours, 11 and a half hours when we started the study. That didn't change over the course of the study. So they did keep their routine the same. No changes there. What did change was that they were much better able to wear the lenses comfortably. So before, when you started the study, they reached around 6 and a half hours. Let's take a typical work day, 8 hours. You would not be able to wear them all day. Now with the lifitegrast drops, what happened was that they improved to 8 hours after 2 weeks use, and then after to 9 hours after 6 and after 12 weeks. So significant improvements participants would now, or lens wearers would now actually get through their full day of lens wear without any issues with their work day at least, and then depending what to do after. So that's important, because we are university. We are a university site, so we are a specific research unit alone. We only see participants. We're not a dry eye practice. We get participants who are signing up for database because they have specific issues. We have lots of students. We have lots of university staff, lots of other professional staff who spend the majority of the day on the computer. So if they reach that, the 9 hours will be largely spent on any digital device. And knowing how much that impacts daily life, we were quite impressed how well the lifitegrast ended up working for us. So they were really, really impressed.

Kaiser Maharjan:

That's fantastic. And was there anything that surprised you throughout the study?

Schulze:

What was surprising, actually, was that participants didn't notice how much better it got. So it was a very odd observation. It's almost you can liken it a little bit to your grandparent. You see grandkids like after 6 months again, they seem to have grown a lot. For the parents who observe it every day, it was marginal. It wasn't that much. It seems to be okay, but not that much. Wearers didn't necessarily notice how much it improved, because it was a gradual improvement. When you showed them what they rated initially, they were like, "It was that bad?" So they were really, really, almost shocked how bad it's been and how much better it had almost become normal now for them to be really good, because after 12 weeks, they didn't expect to have rated 70-80 when they were now at like 0. Some people came back, said, "I think it may have worked a little bit," and they rated a 0, and they came in with a 70. So it was definitely improvements there which were coming a bit out of nowhere, so to say. We didn't expect them to be quite as good.

Kaiser Maharjan:

What are some of the key takeaways that you really want to drive home to optometrists?

Schulze:

Key takeaways are one thing that's really important is patient education beforehand, mainly with regards to the side effects that can occur. Lifitegrast has the side effect of dysgeusia, so there's this unpleasant taste in the mouth. We told everyone in the informed consent letter, also during the screening, this is what you're going to notice. It will happen just that you know it's nothing to worry about. This is just something that happens. It goes away fairly quickly again. When we follow up with participants, when we came back at our respective visits, none of them actually felt this was a reportable incident, unless you specifically asked them, "So how was it with the taste in the mouth?" "Oh yeah, I had that, but he told me about it. I knew about it." So I think what's crucial is teach your patients, or tell your patients, exactly that's going to happen and it will have a much better impact on them, because they know I expected that, no issue for me, I can go with that basically, and they will continue on using it. That was crucial. And obviously you need to educate them on the use of the drops before and after lens use, so that's crucial. They cannot put the drops on top of their lenses. It has to be done before lenses go on, 15 minute wait time at least, and then lenses go on, and in the end, when lens have been removed. But overall, it's been quite impressive. I think there is a lot of really good findings. Key takeaways, I think, for clinicians, is mainly that if they have the patients that struggle with using rewetting drops, only artificial tears, and they cannot get them improved, even with any kind of lens they have that may be worth a try, because it may push them over their required hours for working comfortably at a computer all day.

Kaiser Maharjan:

Absolutely. And is there anything else that you want to mention from the study that I haven't asked you about?

Schulze:

One thing that may be worth mentioning is that we also collected tears. We did collect tears at all of the visits to see whether they were changing the inflammatory markers. We looked at a number of cytokines. Long story short, no, there were no changes in tear markers. And that's simply because we deal with dry eye patients, or these patients have to discomfort with lens wear. The tear film is largely in the lenses to keep them in shape. There was very little tears on their eyes. They came in after 6 hours of use of the lenses. So whatever we were able to collect was not enough, or from what we were able to collect, there were no differences over time. But it was basically not possible for us to measure the tears, probably to measure other changes in cytokine levels. That was something that was interesting. We tried it, but it just did not work out. So we cannot say whether the changes are from any changes there, because it doesn't seem like it. It just really seems to help them with their symptoms, doesn't seem to impact the inflammatory markers so much.

Kaiser Maharjan:

Fantastic. Well, this has been a really great tour through lifitegrast, and it's really interesting to see how it interacts with contact lens wearers. So thank you so much for taking the time today, Dr Schulze.

Schulze:

Awesome. Thanks very much for having me.