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

OBJECTIVE OR PURPOSE: Examine if 12.5 μL timolol maleate 0.5% microdrops dispensed with the Nanodropper® Adaptor provide non-inferior intraocular pressure (IOP) reduction compared to conventional, 28 μL drops in open-angle glaucoma (OAG) and ocular hypertension (OHT) patients.

DESIGN: Prospective, non-inferiority, parallel, multicenter, single-masked, active-controlled, randomized trial.

SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: Treatment-naïve subjects that were recently diagnosed with OAG/OHT at the Aravind Eye Care System.

METHODS, INTERVENTION, OR TESTING: Both eyes of subjects received either one commercially available drop or one 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: 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 to baseline at all timepoints. Non-inferiority was established at three of four timepoints. HR decreases with Nanodropper were ∼3 bpm less than with conventional drops.

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