Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study

Purpose: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. Design: Prospective, open-label, randomized, single-site study. Subjects: Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days. Methods: Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period. Results: Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean TOP from 18.2 +/- 3.8 mmHg to 14.0 +/- 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 +/- 4.3 mmHg to 13.5 +/- 3.7 mmHg. The observed TOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in TOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable. Conclusion: The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.