ILR7: A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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. 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Los Angeles | California | United States | 90027 | |
| 2 | Atlanta | Georgia | United States | 30322 | |
| 3 | Chicago | Illinois | United States | 60611 | |
| 4 | Indianapolis | Indiana | United States | 46202 | |
| 5 | Kansas City | Kansas | United States | 66103 | |
| 6 | Boston | Massachusetts | United States | 02115 | |
| 7 | Detroit | Michigan | United States | 48201 | |
| 8 | Charleston | North Carolina | United States | 29425 | |
| 9 | Nashville | Tennessee | United States | 37232 | |
| 10 | Dallas | Texas | United States | 75390 | |
| 11 | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- Omeros Corporation
Investigators
- Study Director: Steve Whitaker, MD, Omeros Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
- OMS302-ILR-007
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 78 participants enrolled in the study. 6 participants were consented and randomized but did not receive OMS302 or Phenylephrine HCl. Out of the 72 participants who received OMS302 or Phenylephrine HCl, 3 participants did not complete the study. One participant 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. |
| Arm/Group Title | OMS302 | Phenylephrine HCl |
|---|---|---|
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl |
| Period Title: Overall Study | ||
| STARTED | 37 | 41 |
| COMPLETED | 31 | 38 |
| NOT COMPLETED | 6 | 3 |
Baseline Characteristics
| Arm/Group Title | OMS302 | Phenylephrine HCl | Total |
|---|---|---|---|
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl | Total of all reporting groups |
| Overall Participants | 33 | 39 | 72 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
1.0
(1.1)
|
1.4
(1.2)
|
1.2
(1.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
48.5%
|
19
48.7%
|
35
48.6%
|
| Male |
17
51.5%
|
20
51.3%
|
37
51.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
10
25.6%
|
10
13.9%
|
| Not Hispanic or Latino |
33
100%
|
29
74.4%
|
62
86.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
3%
|
0
0%
|
1
1.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
15.2%
|
3
7.7%
|
8
11.1%
|
| White |
26
78.8%
|
30
76.9%
|
56
77.8%
|
| More than one race |
1
3%
|
6
15.4%
|
7
9.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Intraoperative Pupil Diameter |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 61 evaluable videos, one for each subject. |
| Arm/Group Title | OMS302 | Phenylephrine HCl |
|---|---|---|
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl |
| Measure Participants | 30 | 31 |
| Mean (Standard Deviation) [millimeters*minutes] |
0.14
(0.474)
|
0.20
(0.600)
|
| Title | Acute Postoperative Pain |
|---|---|
| Description | 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 |
| Time Frame | 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 71 participants with evaluable postoperative pain scores. |
| Arm/Group Title | OMS302 | Phenylephrine HCl |
|---|---|---|
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl |
| Measure Participants | 33 | 38 |
| Mean (Standard Deviation) [score*hours] |
0.44
(0.742)
|
0.65
(0.943)
|
| Title | Safety as Measured by Treatment-emergent Adverse Events, the Number of Affected Patients/at Risk (%) and the Number of Events. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OMS302 | Phenylephrine HCl |
|---|---|---|
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl |
| Measure Participants | 32 | 40 |
| Count of Participants [Participants] |
15
45.5%
|
18
46.2%
|
Adverse Events
| Time Frame | 90 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. One out of 72 participants was randomized to OMS302 but received Phenylephrine HCl. This participant was included in the Phenylephrine HCl group for safety analyses. | |||
| Arm/Group Title | OMS302 | Phenylephrine HCl | ||
| Arm/Group Description | OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution OMS302 | Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution Phenylephrine HCl | ||
All Cause Mortality |
||||
| OMS302 | Phenylephrine HCl | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 0/40 (0%) | ||
Serious Adverse Events |
||||
| OMS302 | Phenylephrine HCl | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/32 (6.3%) | 0/40 (0%) | ||
| Infections and infestations | ||||
| Bronchiolitis | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Respiratory Syncytial Virus Infection | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| OMS302 | Phenylephrine HCl | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/32 (46.9%) | 18/40 (45%) | ||
| Congenital, familial and genetic disorders | ||||
| Persistent Pupillary Membrane | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Endocrine disorders | ||||
| Hypothyroidism | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Eye disorders | ||||
| Acquired Epiblepharon | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Anisometropia | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Anterior Capsule Contraction | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Anterior Chamber Inflammation | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Anterior Chamber Opacity | 2/32 (6.3%) | 2 | 2/40 (5%) | 2 |
| Conjunctival Haemorrhage | 0/32 (0%) | 0 | 3/40 (7.5%) | 3 |
| Conjunctival Hyperaemia | 1/32 (3.1%) | 1 | 1/40 (2.5%) | 1 |
| Dry Eye | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Eyelid Ptosis | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Iris Adhesions | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Retinal Haemorrhage | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Vitreous Fibrin | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Vitreous Haemorrhage | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Toothache | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Vomiting | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| General disorders | ||||
| Discomfort | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Pain | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Pyrexia | 1/32 (3.1%) | 1 | 3/40 (7.5%) | 3 |
| Immune system disorders | ||||
| Immunisation Reaction | 0/32 (0%) | 0 | 2/40 (5%) | 2 |
| Infections and infestations | ||||
| Bronchiolitis | 2/32 (6.3%) | 2 | 0/40 (0%) | 0 |
| Candidiasis | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Nasopharyngitis | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Respiratory Syncytial Virus Infection | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Upper Respiratory Tract Infection | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Corneal Abrasion | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Eye Injury | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Laceration | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Procedural Pain | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Investigations | ||||
| Intraocular Pressure Increased | 2/32 (6.3%) | 2 | 2/40 (5%) | 2 |
| Renal and urinary disorders | ||||
| Vesicoureteric Reflux | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchial Hyperreactivity | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Cough | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Wheezing | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis Contact | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Eczema | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Pruritus | 1/32 (3.1%) | 1 | 0/40 (0%) | 0 |
| Surgical and medical procedures | ||||
| Eustacian Tube Operation | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
| Vascular disorders | ||||
| Flushing | 0/32 (0%) | 0 | 1/40 (2.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Omeros Clinical Trial Information |
|---|---|
| Organization | Omeros Corporation |
| Phone | ctinfo@omeros.com |
| ctinfo@omeros.com |
- OMS302-ILR-007