The purpose of this study is to determine whether the use of OMS302 (the study drug) in
individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe
and effective at maintaining an adequately dilated pupil during surgery and reducing
post-operative symptoms of discomfort (such as eye pain and irritation).

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Cataract

OMS302 Solution

OMS302 Mydriatic Solution

OMS302 Anti-inflammatory Solution

Balanced Salt Solution (BSS) Solution

Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end
of the surgical procedure (wound closure) was summarized using descriptive statistics by
treatment group and time point. Repeated measures analyses of variance were used to test
for differences in the maintenance of mydriasis. The repeated measures model included
change from baseline pupil diameter as the response variable and treatment (OMS302,
ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the
stratification factor lens opacities classification system II (LOCS II) grade as
predictor variables. A generalized estimating equation (GEE) approach with an AR(1)
working-correlation structure was used.

For the primary analysis of this endpoint, only the results on the day of operation at 2,
4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst
possible pain) were summarized by treatment group and time point. Repeated measures
analyses of variance were used to test for differences in postoperative ocular pain. The
repeated measures model included VAS pain score as the response variable and treatment
(OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical
variable) and the stratification factor LOCS II grade as predictor variables. A
generalized estimating equation (GEE) approach with an AR(1) working correlation
structure was used.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal
Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing,
photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment
comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the
stratification factor LOCS II grade.

The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal
Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing,
photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment
comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the
stratification factor LOCS II grade.

Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic
Retinopathy Study (ETDRS) visual acuity log score. 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. Treatment comparisons for BCVA were performed
by pairwise Wilcoxon tests.

Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score.
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. Treatment
comparisons for BCVA were performed by pairwise Wilcoxon tests.

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

TPostoperative 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

Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, 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

The mean anterior chamber cell count was calculated as the average of the two anterior
chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the
purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of
surgery were summarized.

Ophthalmic anti-inflammatory medications were identified by reviewing concomitant
medications. Subject incidence of ophthalmic anti-inflammatory medication use by
post-surgery day was presented. Treatment comparisons were performed using a
Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II
grade.

Ocular pain medications were identified by reviewing concomitant medications. Subject
incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment
comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the
stratification factor LOCS II grade.

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

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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