An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper

Abstract

Purpose: To examine if 12.5 μl timolol maleate 0.5% microdrops dispensed with the Nanodropper Adaptor provide noninferior intraocular pressure (IOP) reduction compared with conventional 28 μl drops in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).

Design: Prospective, noninferiority, parallel, multicenter, single-masked, active-controlled, randomized trial.

Participants: Treatment-naïve subjects who were recently diagnosed with OAG and OHT at the Aravind Eye Care System.

Methods: Both eyes of subjects received 1 commercially available drop or both eyes of subjects received 1 microdrop of timolol maleate 0.5%. We measured IOP, resting heart rate (HR), and blood pressure (BP) at baseline and 1, 2, 5, and 8 hours after timolol administration.

Main outcome measures: The IOP was the primary outcome measure. Secondary outcomes were resting HR, systolic BP (sBP), and diastolic BP (dBP).

Results: Adaptor-mediated microdrops and conventional drops of timolol significantly decreased IOP compared with baseline at all timepoints. Noninferiority was established at 3 of 4 timepoints. Heart rate decreases with Nanodropper were approximately 3 beats per minute (bpm) less than with conventional drops.

Conclusions: Timolol microdrops appear to be as effective in ocular hypotensive action as conventional drops with a slightly attenuated effect on resting HR and BP.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Keywords: Drug delivery; Eyedrops; Glaucoma; IOP; Microdrops; Ocular hypertension; Timolol maleate.