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CompletedNCT02132312ILR7Updated Jul 22, 2021Results posted

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

A Phase 3 interventional study of OMS302 and Phenylephrine HCl in Unilateral Cataract Extraction and Congenital Cataract, sponsored by Omeros Corporation. Completed at 11 sites in United States. Open to participants aged 1 Day to 47 Months. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Omeros Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
1 Day to 47 Months
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.

Read the detailed description

This study is a randomized, parallel-group, double-masked, phenylephrine-controlled study of OMS302 in young children ages birth through three years undergoing unilateral cataract extraction with or without lens replacement. Administration of test irrigation solutions will take place in a double-masked fashion.

Intraoperative pupil size will be determined by measurement of pupil diameter from still photos captured from video recordings of the procedure. Pupil diameter measurements will be performed immediately prior to the initial incision and at one-minute intervals until the end of the procedure (wound closure). Pain will be assessed by the Alder Hey Triage Pain Score.

02

Conditions studied

  • Unilateral Cataract Extraction
  • Congenital Cataract

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Keywords

  • Cataract
  • Lens replacement
  • pediatric
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 78 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Omeros Corporation is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 47 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Are 0 through three years of age at the time of surgery.
  2. Are to undergo unilateral primary cataract extraction with or without lens replacement.
  3. Have informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization provided by a parent or legal guardian in accordance with local regulations and governing IRB/IEC requirements prior to any procedures or evaluations performed specifically for the sole purpose of this study.
  4. A parent or legal guardian has indicated that they understand and are able, willing, and likely to fully comply with study procedures and restrictions.

Exclusion criteria

Exclusion Criteria:

  1. Corneal diameter less than nine millimeters in the study eye.
  2. Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, or latex.
  3. Surgeon's expectation that the protocol-specified mydriatic regimen will not be adequate to perform the procedure and that additional mydriatic treatment (pharmacological or mechanical) will be required.
  4. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the Investigator.
  5. Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
  6. Use of any topical medication in the study eye within seven days prior to surgery, except for medications needed to examine the eye or prepare for surgery.
  7. Have a post-traumatic cataract.
  8. History of uveitis or evidence of past uveitis such as synechiae or keratic precipitates in the study eye.
  9. Have an ocular neoplasm in the study eye.
  10. Have a clinically significant infection.
  11. Have suspected permanent or low vision in the fellow non-study eye, unless caused by a cataract. The study eye must not be the subject's only good eye.
  12. Use of systemic corticosteroids or NSAIDs in the seven days prior to surgery.
  13. Have a history of clinically significant corticosteroid-induced intraocular pressure increase.
  14. Use of any medication for ocular hypertension or glaucoma in the study eye.
  15. Use of monoamine oxidase inhibitors for 21 days preoperatively.
  16. Prior participation in a clinical study of OMS302.
  17. Participating in any investigational drug or device trial within the 30 days prior to the day of surgery.
  18. History of intraocular non-laser surgery in the study eye within the three months prior to the day of surgery, or intraocular laser surgery in the study eye within 30 days prior to the day of surgery.
  19. Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data.
  20. Be a member of the immediate family of the Investigator or employees of the investigative site. Immediate family is defined as the Investigator's or employees' natural or legally adopted child (including a stepchild living in the Investigator's household), or grandchild.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    OMS302

    OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution

    Drug: OMS302

  • Active comparator
    Phenylephrine HCl

    Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution

    Drug: Phenylephrine HCl

Interventions

  • DrugOMS302
  • DrugPhenylephrine HCl
06

What researchers measure

Primary outcomes

  1. Intraoperative Pupil Diameter

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

    Time frame: 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.

  2. Acute Postoperative Pain

    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

    Time frame: 24 hours

  3. Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.

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

    Time frame: 90 days

07

Results

Posted Jul 22, 2021

Participant flow

Participant flow — Overall Study
MilestoneOMS302Phenylephrine HCl
Started3741
Completed3138
Not completed63
Withdrew: Adverse event20
Withdrew: Physician decision11
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject10
Withdrew: Lost to follow-up21

Outcome measures

PrimaryIntraoperative Pupil Diameter

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

Time frame:
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.
Reported as:
Mean · millimeters*minutes
Intraoperative Pupil Diameter
millimeters*minutesOMS302Phenylephrine HCl
Intraoperative Pupil Diameter0.14 ± 0.4740.20 ± 0.600
PrimaryAcute Postoperative Pain

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

Time frame:
24 hours
Reported as:
Mean · score*hours
Acute Postoperative Pain
score*hoursOMS302Phenylephrine HCl
Acute Postoperative Pain0.44 ± 0.7420.65 ± 0.943
PrimarySafety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.

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

Time frame:
90 days
Reported as:
Count of participants · Participants
Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.
ParticipantsOMS302Phenylephrine HCl
Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.1518

Adverse events

Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OMS3020/32 (0%)2/32 (6.3%)15/32 (46.9%)
Phenylephrine HCl0/40 (0%)0/40 (0%)18/40 (45%)
Most frequent serious events
Most frequent serious events
EventOMS302Phenylephrine HCl
BronchiolitisInfections and infestations1/320/40
Respiratory Syncytial Virus InfectionInfections and infestations1/320/40
Most frequent other events
Showing 10 of 41
Most frequent other events
EventOMS302Phenylephrine HCl
Conjunctival HaemorrhageEye disorders0/323/40
PyrexiaGeneral disorders1/323/40
Anterior Chamber OpacityEye disorders2/322/40
BronchiolitisInfections and infestations2/320/40
Intraocular Pressure IncreasedInvestigations2/322/40
Immunisation ReactionImmune system disorders0/322/40
Persistent Pupillary MembraneCongenital, familial and genetic disorders1/320/40
Anterior Chamber InflammationEye disorders1/320/40
Conjunctival HyperaemiaEye disorders1/321/40
Dry EyeEye disorders1/320/40

Baseline characteristics

78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. One out of 72 participants 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.

Age, Continuous
Age, Continuous(years)OMS302Phenylephrine HClTotal
Mean1.0 ± 1.11.4 ± 1.21.2 ± 1.2
Sex: Female, Male
Sex: Female, Male(Participants)OMS302Phenylephrine HClTotal
Female161935
Male172037
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)OMS302Phenylephrine HClTotal
Hispanic or Latino01010
Not Hispanic or Latino332962
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)OMS302Phenylephrine HClTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American538
White263056
More than one race167
Unknown or Not Reported000
08

Study locations

11 sites
  • Los Angeles, California 90027, United States
  • Atlanta, Georgia 30322, United States
  • Chicago, Illinois 60611, United States
  • Indianapolis, Indiana 46202, United States
  • Kansas City, Kansas 66103, United States
  • Boston, Massachusetts 02115, United States
  • Detroit, Michigan 48201, United States
  • Charleston, North Carolina 29425, United States
  • Nashville, Tennessee 37232, United States
  • Dallas, Texas 75390, United States
  • Madison, Wisconsin 53705, United States
09

References and documents

Publications

  • Wilson ME, Trivedi RH, Plager DA. Safety and efficacy data supporting U.S. FDA approval of intracameral phenylephrine and ketorolac 1.0%/0.3% for pediatric cataract surgery: clinical safety and pupil and pain management. J Cataract Refract Surg. 2020 Jun;46(6):873-878. doi: 10.1097/j.jcrs.0000000000000194. PubMed 32221151 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02132312
Lead sponsor
Omeros Corporation
Responsible party
Sponsor
First posted
May 7, 2014
Start date
Jul 2014
Primary completion
Sep 12, 2016
Completion
Sep 12, 2016
Results posted
Jul 22, 2021
Last update
Jul 22, 2021

Study contacts

Steve Whitaker, MD
study director · Omeros Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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