Study Patient

I enrolled Tommy in an ophthalmology study a few weeks ago when he first developed high ocular pressures.  Tommy is exceptionally patient with eye exams and all other matters of poking and prodding.  (I think this is related to the fact that he is kid #4 and has endured countless hours of poking and prodding from his 3 older sisters)  Our doctor said the study was low on kids under 3 years old, since most are not super-compliant with eye exams, so he'd really like Tommy to be a part of the study.

New glaucoma suspect- pressure of 23

This particular study is designed to compare 2 different eye drops in children.  Neither of them carries an FDA approval for use in children, however, due to extensive experience with one (timolol), over time, it has become standard therapy for pediatric glaucoma.  This is sponsored by another company hoping to gain FDA approval in pediatric patients for their drug.  (I'm intentionally not mentioning the other drug)  Most studies offer their subjects some type of compensation for study visits, usually a nominal amount of money for gas or a gift card.  This study has a generous compensation, however, the real reason we decided to enroll Tommy is that we get to keep a really close eye on his pressures.  There are 4 study visits (baseline, 2 weeks,  6 weeks, and  12 weeks).  At each study visit there is a complete eye exam (with pressure checks and measurements), blood pressure, and heart rate measurements.  At baseline and 12 week visits there is also an EKG measurement.  The EKG, blood pressure, and heart rate checks are likely due to the effects that timolol can have on the heart if it gets systemically absorbed.  Each study subject is randomized to get timolol or this other drug.  Since I know that both drugs are proven to work in glaucoma (even if it is in adult patients), I felt comfortable.  I would not have joined a placebo controlled study, I was paranoid enough about this new diagnosis!  We had to instill drops into his eye twice daily- at set times 12 hours apart.  That part is more challenging that I thought!

Eye drop technique is important in these drops, a significant amount can be absorbed if it isn't administered correctly.  I was surprised that the study coordinator did not go over this with us extensively.  In fact, we had no instruction at all!  Tommy's dad and I are both pharmacists, so we know the proper way.  You need to create a pocket with the lower lid, put a drop in, then put pressure on the corner of the eye where it meets the nose for ~30 seconds to 1 minute to minimize absorption.  We had this down, but I do wish this was more widely circulated.  (I'm thinking about creating a video for another post)

Pressure is 34- yuck!

 

I love knowing the eye pressures so frequently.  I'm happy to report that Tommy's pressure is down to 16 mmHg in the eye that has glaucoma.  Awesome news- since his baseline was ~17.  I watched it steadily decrease, and felt a small victory each time it was a little lower.  Since he received the diagnosis at a pressure of 23, and the baseline pressure was 32, I am thrilled.  The only thing I don't love is that our PO is a little more focused on completing all the study paperwork.  There are a lot more boxes to check, t's to cross, and i's to dot than our normal visits.  He spends a little more time staring at the computer than usual (side note, this is a problem happening in all of medicine that has nothing to do with study visits, but that is for another blog!)  We still love him, but  I will be a little glad to get back to a more Tommy-centric visit.  Tommy is a champ- but these visits take a little longer than usual, and he is a little antsy by the time it is all over.  His backpack full of tricks only lasts so long.

Pressure is 24!

Before we started the study, Tommy was put on timolol, 1 drop twice daily.  He was only on it for a few weeks, but it didn't appear to be working.  His initial "bad" pressure was 23, our PO's low threshold for treating.  At the baseline study visit, Tommy's pressure was 34 mmHg.  I was panicking- and when the PO didn't mention it, I was just a little more than stressed out.  When I asked him about it, he really and truly was not worried.  Apparently, the amount of cooperation from a child really matters in these pressure readings.  If you squint at all, the pressure increases.  Even good patients have difficulty with this.  By the second study visit, Tommy and I had a trick.  If I got him to focus on an object at the back of the room (our PO has movies playing) then he was so busy trying to spot what I spotted, he didn't squint, and the pressures were better.  By the 2nd visit, pressure was down to 24, and I don't know if this is study drug effect or good technique.  At the 3rd study visit, it was down to 16- and I don't really care if it is study drug or technique- it's better!!!

Happy day!  Eye pressure down to 16!

Yay for good pressure readings!  But now is the next dilemma- which study drug is he on?  He had started on timolol, but the pressures increased.  That leads me to believe that it could be the other drug.  I asked if the study would be un-blinded at the end (and since the company reached enrollment, the study is now closed).  The study coordinator is looking into it.  I'm thinking he is on "the other drug".  That drug is usually given only at night.  While we have a bottle for morning drops and a bottle for evening drops, Tommy only complains about the evening drops "it hurts".  (Those have to be some of the saddest words your child can say to you as you are doing your best to help him).  Hopefully they will un-blind it so we can continue on this drug that is working!

What is it really like though?  I wish I could ask Tommy.  He really doesn't seem to mind the visits- he gets a lot of attention from the assistants and the study coordinator.  The love him, and he loves to show off for them.  Last time he drew them all pictures, which made them melt.  I'm as proud as I can be- he tolerates all of this so much better than I could ever hope for.  Every morning and every night I poke in his eye to get the contact in or out, put drops in, patch him... and all he ever really says is "it's uncomforbull" or "it's gonna hurt!", occasionally, "no, mommy, no"  But no tears, no screaming.  Little trouper.  While I do realize that a lot of kids are going through a lot more, it is still never easy to see your baby go through any discomfort.

The following are just some random cute pics!

Ring bearer Tommy! (or as he said, "I not ring bear, I ring BOY"

Partied out.


 

Tommy selfie