Trial · NCT02132312
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
NCT02132312, Phase 3, Completed, Omeros Corporation; results first posted 2021-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement. Trials, record NCT02132312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02132312
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
- NCT number
- NCT02132312
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 78 participants, actual
- Lead sponsor
- Omeros Corporation
- Conditions
- Unilateral Cataract Extraction, Congenital Cataract
- Interventions
- OMS302, Phenylephrine HCl
- First posted
- 2014-05-07
- Last updated
- 2021-07-22
- Results first posted
- 2021-07-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Pupil Diameter | 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. | Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos. |
| Primary | Acute Postoperative Pain | 24 hours | 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 |
| Primary | Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. | 90 days | Safety as assessed by the incidence of adverse events and serious adverse events up until the last visit at Day 90. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraoperative Pupil Diameter | 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. | There were 61 evaluable videos, one for each subject. | millimeters*minutes | MEAN |
| PRIMARY | Acute Postoperative Pain | 24 hours | There were 71 participants with evaluable postoperative pain scores. | score*hours | MEAN |
| PRIMARY | Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. | 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. 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraoperative Pupil Diameter | OMS302 | 0.14 | Standard Deviation 0.474 | millimeters*minutes | |
| Intraoperative Pupil Diameter | Phenylephrine HCl | 0.20 | Standard Deviation 0.600 | millimeters*minutes | |
| Acute Postoperative Pain | OMS302 | 0.44 | Standard Deviation 0.742 | score*hours | |
| Acute Postoperative Pain | Phenylephrine HCl | 0.65 | Standard Deviation 0.943 | score*hours | |
| Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. | OMS302 | 15 | Participants | ||
| Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. | Phenylephrine HCl | 18 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OMS302 | 37 | |
| Overall Study | STARTED | Phenylephrine HCl | 41 | |
| Overall Study | COMPLETED | OMS302 | 31 | |
| Overall Study | COMPLETED | Phenylephrine HCl | 38 | |
| Overall Study | NOT COMPLETED | OMS302 | 6 | |
| Overall Study | NOT COMPLETED | Phenylephrine HCl | 3 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Persistent Pupillary Membrane | Congenital, familial and genetic disorders | OMS302 | 1 | 32 | 1 |
| other | Persistent Pupillary Membrane | Congenital, familial and genetic disorders | Phenylephrine HCl | 0 | 40 | 0 |
| other | Hypothyroidism | Endocrine disorders | OMS302 | 0 | 32 | 0 |
| other | Hypothyroidism | Endocrine disorders | Phenylephrine HCl | 1 | 40 | 1 |
| other | Acquired Epiblepharon | Eye disorders | OMS302 | 0 | 32 | 0 |
| other | Acquired Epiblepharon | Eye disorders | Phenylephrine HCl | 1 | 40 | 1 |
| other | Anisometropia | Eye disorders | OMS302 | 0 | 32 | 0 |
| other | Anisometropia | Eye disorders | Phenylephrine HCl | 1 | 40 | 1 |
| other | Anterior Capsule Contraction | Eye disorders | OMS302 | 0 | 32 | 0 |
| other | Anterior Capsule Contraction | Eye disorders | Phenylephrine HCl | 1 | 40 | 1 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OMS302 | 0 | 32 |
| Total, all-cause mortality | Phenylephrine HCl | 0 | 40 |
| Total, other adverse events | OMS302 | 15 | 32 |
| Total, other adverse events | Phenylephrine HCl | 18 | 40 |
| Total, serious adverse events | OMS302 | 2 | 32 |
| Total, serious adverse events | Phenylephrine HCl | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32221151 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OMS302 vs Phenylephrine HCl: Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. | Trial comparisons |
| OMS302 vs Phenylephrine HCl: deaths from any cause | Trial comparisons |
| OMS302 vs Phenylephrine HCl: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02132312
GET https://conductscience.org/api/trials/v1/NCT02132312/events?page=2