Phase
Condition
Eye Disorders/infections
Eye Disease
Vision Loss
Treatment
N/AClinical Study ID
Ages < 47 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Are 0 through three years of age at the time of surgery.
- Are to undergo unilateral primary cataract extraction with or without lensreplacement.
- Have informed consent and Health Insurance Portability and Accountability Act (HIPAA)Authorization provided by a parent or legal guardian in accordance with localregulations and governing IRB/IEC requirements prior to any procedures or evaluationsperformed 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
Exclusion Criteria:
- Corneal diameter less than nine millimeters in the study eye.
- Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, orlatex.
- Surgeon's expectation that the protocol-specified mydriatic regimen will not beadequate 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 medicalcondition that could increase the risk to the subject as determined by theInvestigator.
- 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 keraticprecipitates 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 acataract. 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 pressureincrease.
- 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 tothe day of surgery.
- History of intraocular non-laser surgery in the study eye within the three monthsprior to the day of surgery, or intraocular laser surgery in the study eye within 30days prior to the day of surgery.
- Presence of any condition that the Investigator believes would put the subject at riskor confound the interpretation of the study data.
- Be a member of the immediate family of the Investigator or employees of theinvestigative site. Immediate family is defined as the Investigator's or employees'natural or legally adopted child (including a stepchild living in the Investigator'shousehold), or grandchild.
Study Design
Study Description
Connect with a study center
Los Angeles, California 90027
United StatesSite Not Available
Atlanta, Georgia 30322
United StatesSite Not Available
Chicago, Illinois 60611
United StatesSite Not Available
Indianapolis, Indiana 46202
United StatesSite Not Available
Kansas City, Kansas 66103
United StatesSite Not Available
Boston, Massachusetts 02115
United StatesSite Not Available
Detroit, Michigan 48201
United StatesSite Not Available
Charleston, North Carolina 29425
United StatesSite Not Available
Nashville, Tennessee 37232
United StatesSite Not Available
Dallas, Texas 75390
United StatesSite Not Available
Madison, Wisconsin 53705
United StatesSite Not Available
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