Correlation of 1.5% EV06 Ophthalmic Eye Drop Formulation (NCT02516306) Snellen scores (logMAR) results with ex parte clinical accommodation (diopters) measurements

Abstract

Purpose : Determine an equation to convert logMAR units acquired in our clinical study to diopters.

Methods : Diopter value was calculated using ∂D(AGE)=7.081/(1+EXP(0.2031*((AGE-36.2)-0.6109))) developed by Anderson et al [IOVS (2008), 49: 2919-2926]. Data collected from the EV06 study was used to construct XY-scatter plots. GraphPad was then used to determine a best-fit equation to logMAR with age. Subsequently, an equation was then found to calculate diopters as a function of logMAR. iTrace aberrometry measurements were obtained for objective analysis.

Results : The fitted solidline in Figure 1 using equation logMAR(AGE)= 6.8985*(EXP((-3.5413)*AGE^0.4695))) predicts an equivalent age (closed green circles) with logMAR values. Equation Diopter(logMAR) = (6.898)*(EXP(-3.541*logMAR^0.469)) provides the fitted dotted line shown in Figure 2 to calculate the expected diopter value using the clinical derived logMAR value.

Conclusions : Figures show logMAR scores changed inversely to accommodative amplitude measured by diopters. A numerical relationship was derived to determine an expected diopter change from the measured EV06 logMAR score results. The equation demonstrates diopter magnitude of change increases from +0.5D (average on DAY-1) to more than +1D in over 50% of the patients with EV06 treatment. Using the logMAR transformation equation demonstrates that the 1.5% EV06 Ophthalmic Formulation significantly (P<0.001) improves diopter response compared to placebo group over the 91-DAY treatment duration.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Inner box encloses patient scores aged between 45 and 55-years (open red circles ranging from 0.3 to 0.8 logMAR units left axis). Corresponding patient logMAR scores are shown (open green circles) at DAY-91. The scatter plot also shows the non-linear fit (solid line) to logMAR values collected from the reference literature (black circles) combined with the EV06 DAY-1 logMAR measurements. Accommodative amplitude loss is indicated with dashed line with diopter units right Y-axis).

 

The Scatter Plot shows the relationship of logMAR (open red circles) measured at DAY-1 (X-axis) to expected diopters of accommodation (Y-axis). The closed green circles represent derived diopter values based on DAY-91 logMAR. Using initial logMAR DAY-1help visualize the EV06 treatment effects on diopter change that occurs from DAY-1 to DAY-91 (open green circles).