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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Unilateral Cataract Extraction, Congenital Cataract

Intervention / Treatment
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* Drug: OMS302
* Drug: Phenylephrine HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMS302<br>OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution | Drug: OMS302<br> <br> |
| Active Comparator: Phenylephrine HCl<br>Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution | Drug: Phenylephrine HCl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Cry or voice, 0=no compliant/cry, 1=Consolable, 2=Inconsolable Facial Expression, 0=Normal, 1=Short grimace <50% of time, 2=Long grimace >50% of time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Lens replacement, pediatric