Real-world efficacy, safety, and usability of a microvolume eyedrop delivery device in glaucoma: prospective randomized crossover trial.

PURPOSE: Comparing the intraocular pressure lowering (IOP-L) of microdrops (MD) dispensed with the Nanodropper with conventional drops (CD) in patients on IOP-L monotherapy.

SETTING

Outpatient clinic.

DESIGN

Prospective, crossover, examiner-masked, active-controlled, randomized trial conducted at a single center.

METHODS

We enrolled adults with stable primary glaucoma or ocular hypertension on monotherapy with either latanoprost 0.005% or timolol maleate 0.5%. Participants self-administered either CD or MD for 12 weeks, then crossed over to the alternate treatment for an additional 12 weeks. The primary outcome was IOP at 12 weeks compared with baseline at enrollment. Secondary outcomes included running out of drops (premature bottle exhaustion or PBE), adverse effects (AEs), and subjective evaluations of the device's usability.

RESULTS

29 participants completed the study. MD significantly decreased IOP from baseline by 1.6 mm Hg (95% CI 0.88-2.29), compared with a CD (0.13 mm Hg, 95% CI -0.26 to 0.52). Incidence of PBE decreased from 83% with CD to 17% with MD. AEs were reduced from 83% of participants reporting at least 1 AE with CD vs 62% with MD. Most found MD easy to administer and believed it helped prevent eyedrop waste.

CONCLUSIONS

MD delivered with the Nanodropper adaptor provided additional IOP-L, significantly reduced PBE, and decreased the occurrence and severity of nonsystemic AEs compared with CD in this cohort of stable primary open-angle glaucoma/ocular hypertension participants. MD use among glaucoma participants may enhance tolerability, and improve adherence and long-term IOP control.