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

NCT02132312 | Completed Phase 3 Results

• 1 other identifier: OMS302-ILR-007
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Unilateral Cataract Extraction; Congenital Cataract

Keywords

Cataract; Lens replacement; pediatric

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  90 days

Study Arms (2)

OMS302

EXPERIMENTAL

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

Drug: OMS302

Phenylephrine HCl

ACTIVE COMPARATOR

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

Drug: Phenylephrine HCl

Interventions

OMS302 DRUG

OMS302

Phenylephrine HCl DRUG

Phenylephrine HCl

Eligibility Criteria

• Age: 1 Day - 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (11)

Unknown Facility

Los Angeles, California, 90027, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Kansas City, Kansas, 66103, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Charleston, North Carolina, 29425, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Dallas, Texas, 75390, United States

Location

Unknown Facility

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• 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.

  PMID: 32221151 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Omeros Clinical Trial Information
• Organization: Omeros Corporation

ctinfo@omeros.com

ctinfo@omeros.com

Study Officials

• Steve Whitaker, MD

  Omeros Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 7, 2014
• Study Start: July 1, 2014
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: July 22, 2021
• Results First Posted: July 22, 2021

Record last verified: 2021-07

Locations

US (11)