Abstract
Purpose :
Open-angle glaucoma (OAG) and ocular hypertension (OHT) treatment may involve daily administration of intraocular pressure-lowering (IOP-L) eyedrops, yet 30-80% of glaucoma patients do not adhere to their treatments. Microdrops (MD; <20 µL) have been shown in an acute setting (< 24 hours) to have comparable efficacy and improved side effect profiles compared to conventional eyedrops (CD; >20 µL) and may extend bottle life. We performed a prospective, non-inferiority, crossover, single-masked, randomized, active-controlled trial in OAG/OHT patients to evaluate the effects of IOP-L MD administered with the Nanodropper® eyedrop bottle adaptor over a 3-month period on IOP, premature bottle exhaustion (PBE), and side effects compared to the use of CD.
Methods :
Twenty-nine stable OAG/OHT subjects on latanoprost 0.005% (n = 20) or timolol maleate 0.5% (n = 9) were enrolled in this two-period crossover study. Subjects were randomized to administer CD or MD of their IOP-L eyedrops for 3 months before crossing over to the other treatment. IOP, side effects, and PBE were assessed at baseline, crossover, and final visits.
Results :
Results are reported as mean ± SD. Compared to baseline IOP of 16.5 ± 2.8 mm Hg, 3 months of treatment with CD and MD decreased IOP by 0.2 ± 1.1 mm Hg to 16.3 ± 2.8 mm Hg (p=0.408) and 1.6 ± 2.0 mm Hg to 14.9 ± 2.9 mm Hg (p=0.0002), respectively. The relative IOP decreases (i.e., percentage decrease from baseline) were 0.9 ± 6.5% (p=0.484) and 9.4 ± 11.4% (p=0.0001) in the CD and MD groups, respectively. 80% and 17.2% of subjects experienced PBE (i.e., ran out of their eyedrops before the end of the month) at least once during treatment with CD and MD, respectively. Treatment with MD reduced the total number of PBE events by 87.2%, from 39 in the CD group to 5 in the MD group (p<0.0001). Side effects prevalence following treatment with CD and MD were 34 ± 26.1% and 11.5 ± 12.3%, respectively (p=0.0016). Totaling the count x severity (scale of 1 to 5 where 1 is mild and 5 is severe) of the 14 assessed side effects, treatment with MD decreased this metric by 70.4%, from 203 in the CD group to 60 in the MD group (p=0.0014).
Conclusions :
MD provided improved IOP-L efficacy and decreased prevalence of PBE events and side effects compared to CD in this cohort of OAG/OHT patients.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.