The purpose of this study is to determine the safety, efficacy and pharmacokinetics of
OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post
operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

Intraocular Lens Replacement

OMS302

Placebo

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

The co-primary analysis of the change in pupil diameter based on the mean area under the
curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter
from surgical baseline to wound closure was calculated using the trapezoidal rule.
Second, the mean AUC was obtained by dividing the AUC by the total time of surgery.
Third, the mean AUC of change from baseline was calculated by subtracting the baseline
pupil diameter from the mean AUC.

The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst
possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain
VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the
hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the
AUC divided by the number of hours with ocular pain VAS results during the first 12 hours
postoperatively.

The number of subjects with pupil diameter of at least 6 mm at the completion of cortical
clean up summarized by treatment arm. The last pupil diameter was used if not available
at completion of cortical clean up.

The number of subjects with pupil diameter less than 6 mm at any time during surgery
summarized by treatment arm.

The number of subjects with moderate -to-severe pain (VAS greater than or equal to 40) at
any time point during 12 hours postoperatively summarized by treatment arm.

The number of subjects who report ocular pain-free status (VAS equal to 0) at all time
points during 12 hours postoperatively summarized by treatment arm. Subjects with missing
VAS scores during the 12 hours postoperatively were considered as not being pain-free.

VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of
surgery summarized by treatment arm and time point.

Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical
Rating System - NRS) at each time point.

Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS),
summarized by treatment arm and time point. Ocular inflammation was evaluated by
measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS
was calculated by adding the average of subject's anterior chamber cells and flare
grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum
SOIS was 8.

Grading was as follows:

Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade
Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30
cells.

Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely
discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in
anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe =
+4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic
Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g.,
subject could not read enough letters to obtain a score or refraction was not completed)
was also summarized. For subjects without a score due to inability to read the ETDRS
chart, the log score was imputed as 1.6 for the purpose of treatment comparisons.
Subjects without a score because the manifest refraction was not completed were excluded
from the analysis.

Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in
a subset of subjects. Descriptive summary statistics for
area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time
to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured
plasma concentrations were adequate for analysis. Descriptive statistics for
pharmacokinetics were not performed as detected concentrations were low and insufficient
for analysis.

OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during
Intraocular Lens Replacement surgery.

Placebo diluted in Balanced Salt Solution and administered as irrigation solution during
Intraocular Lens Replacement surgery.

Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

About this trial

Study ID

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Type

Phase

Placebo

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Trial Timing

What is this trial about?

What are the participation requirements?

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