Trial Outcomes & Findings for A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement (NCT NCT02132312)

NCT ID: NCT02132312

Last Updated: 2021-07-22

Results Overview

Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 78 participants
• Primary outcome timeframe: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure), the mean time of surgery duration is 35.46 minutes with a standard deviation of 19.98.
• Results posted on: 2021-07-22

Participant Flow

78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Out of the 72 participants who received OMS302 or Phenylephrine HCl, 3 participants did not complete the study. One participant was randomized to OMS302, but received Phenylephrine HCl. This participant was included in the OMS302 group in baseline analyses and in the Phenylephrine HCl group in safety analyses.

Participant milestones

Measure	OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Overall Study STARTED	37	41
Overall Study COMPLETED	31	38
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	OMS302 OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Overall Study Adverse Event	2	0
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

Baseline characteristics by cohort

Measure	OMS302 n=33 Participants OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=39 Participants Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl	Total n=72 Participants Total of all reporting groups
Age, Continuous	1.0 years STANDARD_DEVIATION 1.1 • n=5 Participants	1.4 years STANDARD_DEVIATION 1.2 • n=7 Participants	1.2 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure), the mean time of surgery duration is 35.46 minutes with a standard deviation of 19.98.

Population: There were 61 evaluable videos, one for each subject.

Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos.

Outcome measures

Measure	OMS302 n=30 Participants OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=31 Participants Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Intraoperative Pupil Diameter	0.14 millimeters*minutes Standard Deviation 0.474	0.20 millimeters*minutes Standard Deviation 0.600

PRIMARY outcome

Timeframe: 24 hours

Population: There were 71 participants with evaluable postoperative pain scores.

Mean AUC Analysis of Postoperative pain as measured using the Alder Hey Triage Pain Score at 3, 6, 9, and 24 hours after surgery. The primary analysis of Alder Hey Triage Pain Score was similar to the primary analysis of the change in pupil diameter using AUC. The Alder Hey Triage Pain Score identifies five categories of observations: voice/cry, facial expression, posture, movement, and color. Each of these has a possible score of 0, 1, or 2, resulting in a total score ranging between 0 and 10. A total score of zero means the subject experienced no pain, as the 5 categories added up totals zero. A total score of 10 means the subject experienced a lot of pain and is the worst possible outcome, as the 5 categories added up totals 10.

Parent responses in a diary with a score of 0, 1, or 2.

1. Cry or voice, 0=no compliant/cry, 1=Consolable, 2=Inconsolable

2. Facial Expression, 0=Normal, 1=Short grimace <50% of time, 2=Long grimace >50% of time

3. Posture, 0=Normal, 1=Touching/rub

Outcome measures

Measure	OMS302 n=33 Participants OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=38 Participants Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Acute Postoperative Pain	0.44 score*hours Standard Deviation 0.742	0.65 score*hours Standard Deviation 0.943

PRIMARY outcome

Timeframe: 90 days

Population: 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. Out of the 72 participants, one participant was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.

Safety as assessed by the incidence of adverse events and serious adverse events up until the last visit at Day 90.

Outcome measures

Measure	OMS302 n=32 Participants OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=40 Participants Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.	15 Participants	18 Participants

Adverse Events

OMS302

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Phenylephrine HCl

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	OMS302 n=32 participants at risk OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=40 participants at risk Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Infections and infestations Bronchiolitis	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Respiratory Syncytial Virus Infection	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.

Other adverse events

Measure	OMS302 n=32 participants at risk OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302	Phenylephrine HCl n=40 participants at risk Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl
Congenital, familial and genetic disorders Persistent Pupillary Membrane	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Endocrine disorders Hypothyroidism	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Acquired Epiblepharon	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Anisometropia	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Anterior Capsule Contraction	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Anterior Chamber Inflammation	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Anterior Chamber Opacity	6.2% 2/32 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	5.0% 2/40 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Conjunctival Haemorrhage	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	7.5% 3/40 • Number of events 3 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Conjunctival Hyperaemia	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Dry Eye	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Eyelid Ptosis	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Iris Adhesions	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Retinal Haemorrhage	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Vitreous Fibrin	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Eye disorders Vitreous Haemorrhage	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Gastrointestinal disorders Diarrhoea	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Gastrointestinal disorders Toothache	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Gastrointestinal disorders Vomiting	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
General disorders Discomfort	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
General disorders Pain	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
General disorders Pyrexia	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	7.5% 3/40 • Number of events 3 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Immune system disorders Immunisation Reaction	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	5.0% 2/40 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Bronchiolitis	6.2% 2/32 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Candidiasis	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Nasopharyngitis	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Respiratory Syncytial Virus Infection	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Infections and infestations Upper Respiratory Tract Infection	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Injury, poisoning and procedural complications Corneal Abrasion	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Injury, poisoning and procedural complications Eye Injury	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Injury, poisoning and procedural complications Laceration	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Injury, poisoning and procedural complications Procedural Pain	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Investigations Intraocular Pressure Increased	6.2% 2/32 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	5.0% 2/40 • Number of events 2 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Renal and urinary disorders Vesicoureteric Reflux	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Skin and subcutaneous tissue disorders Eczema	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Skin and subcutaneous tissue disorders Pruritus	3.1% 1/32 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	0.00% 0/40 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Surgical and medical procedures Eustacian Tube Operation	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.
Vascular disorders Flushing	0.00% 0/32 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.	2.5% 1/40 • Number of events 1 • 90 days 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Safety analyses were based on the safety population. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses.

Additional Information

Omeros Clinical Trial Information

Omeros Corporation

Phone: ctinfo@omeros.com

Email: ctinfo@omeros.com

Results disclosure agreements

• Principal investigator is a sponsor employee
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