Unilateral Cataract ExtractionPhase 3ILR7NCT02132312

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

A Phase 3 study testing OMS302 and Phenylephrine HCl in people with Unilateral Cataract Extraction and Congenital Cataract, run by Omeros Corporation at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 1 day to 47 months
Conditions the study is for: Unilateral Cataract Extraction, Congenital Cataract
What is being tested?: OMS302 and Phenylephrine HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 11 sitesUnited States
Study dates: Jul 2014to 12 Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 47 months
All sexes
No healthy volunteers
Child

Who may be able to join

Are 0 through three years of age at the time of surgery.
Are to undergo unilateral primary cataract extraction with or without lens replacement.
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.
A parent or legal guardian has indicated that they understand and are able, willing, and likely to fully comply with study procedures and restrictions.

Who cannot join

Corneal diameter less than nine millimeters in the study eye.
Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, or latex.
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.
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.
Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
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.

Show all 20Show fewer

Have a post-traumatic cataract.
History of uveitis or evidence of past uveitis such as synechiae or keratic precipitates in the study eye.
Have an ocular neoplasm in the study eye.
Have a clinically significant infection.
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.
Use of systemic corticosteroids or NSAIDs in the seven days prior to surgery.
Have a history of clinically significant corticosteroid-induced intraocular pressure increase.
Use of any medication for ocular hypertension or glaucoma in the study eye.
Use of monoamine oxidase inhibitors for 21 days preoperatively.
Prior participation in a clinical study of OMS302.
Participating in any investigational drug or device trial within the 30 days prior to the day of surgery.
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.
Presence of any condition that the Investigator believes would put the subject at risk or confound the interpretation of the study data.
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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

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.

Conditions: Unilateral Cataract Extraction, Congenital Cataract
Being tested: OMS302, Phenylephrine HCl
Keywords: Cataract, Lens replacement, pediatric
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OMS302Drug
Phenylephrine HClDrug

Study groups in NCT02132312
Study group	Role	What they receive
OMS302	Experimental	OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution Receives: Drug: OMS302
Phenylephrine HCl	Active comparator	Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Receives: Drug: Phenylephrine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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
Measured: 24 hours
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.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201412 Sep 2016

First posted7 May 2014 (estimated)
Study startJul 2014
Primary completion12 Sep 2016
Study completion12 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Unilateral Cataract ExtractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02132312
Sponsor's protocol ID: OMS302-ILR-007
Acronym: ILR7
Status last verified: Jul 2021
First submitted: 1 May 2014
Last updated: 22 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
ClinicalTrials.gov ID: NCT02132312
Acronym / sponsor ID: ILR7 / OMS302-ILR-007
Conditions: Unilateral Cataract Extraction, Congenital Cataract
Keywords: Cataract, Lens replacement, pediatric
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Omeros CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: 12 Sep 2016 (actual)
Study completion: 12 Sep 2016 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 22 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OMS302	Experimental	Drug: OMS302OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution
Phenylephrine HCl	Active comparator	Drug: Phenylephrine HClPhenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution

Who may qualify

Ages: 1 day to 47 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Are 0 through three years of age at the time of surgery.
Are to undergo unilateral primary cataract extraction with or without lens replacement.
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.
A parent or legal guardian has indicated that they understand and are able, willing, and likely to fully comply with study procedures and restrictions.

Key exclusion criteria (20 listed)

Corneal diameter less than nine millimeters in the study eye.
Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, or latex.
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.
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.
Presence of active or suspected viral, bacterial, or fungal disease in the study eye.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OMS302	Drug	OMS302
Phenylephrine HCl	Drug	Phenylephrine HCl

Primary outcome

Intraoperative Pupil Diameter
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.
Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos.
Acute Postoperative Pain
Time frame: 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
Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events.
Time frame: 90 days
Safety as assessed by the incidence of adverse events and serious adverse events up until the last visit at Day 90.

Results and safety

Results posted to the registry on 22 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OMS302	37	31
Phenylephrine HCl	41	38

Primary outcome: Intraoperative Pupil Diameter

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.. Mean (Standard Deviation). Unit: millimeters*minutes

Measure	OMS302 n = 30	Phenylephrine HCl n = 31
Value	0.14 (0.474)	0.20 (0.600)

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

Primary outcome: Acute Postoperative Pain

Time frame: 24 hours. Mean (Standard Deviation). Unit: score*hours

Measure	OMS302 n = 33	Phenylephrine HCl n = 38
Value	0.44 (0.742)	0.65 (0.943)

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

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

Time frame: 90 days. Count of participants. Unit: Participants

Measure	OMS302 n = 32	Phenylephrine HCl n = 40
Value	15	18

Population analysed: 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.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OMS302	2 of 32 (6.3%)	15 of 32 (46.9%)	0 of 32
Phenylephrine HCl	0 of 40 (0%)	18 of 40 (45%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32221151Wilson 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steve Whitaker, MD study director

Omeros Corporation

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OMS302 and Phenylephrine HCl in people with Unilateral Cataract Extraction and Congenital Cataract, run by Omeros Corporation at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Pupil Diameter (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02132312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.