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

Last updated: July 1, 2021
Sponsor: Omeros Corporation
Overall Status: Completed

Phase

3

Condition

Eye Disorders/infections

Eye Disease

Vision Loss

Treatment

N/A

Clinical Study ID

NCT02132312
OMS302-ILR-007
  • Ages < 47
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are 0 through three years of age at the time of surgery.
  2. Are to undergo unilateral primary cataract extraction with or without lensreplacement.
  3. 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.
  4. 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:

  1. Corneal diameter less than nine millimeters in the study eye.
  2. Hypersensitivity to phenylephrine, ketorolac, or other NSAIDs, including aspirin, orlatex.
  3. 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.
  4. 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.
  5. Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
  6. 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.
  7. Have a post-traumatic cataract.
  8. History of uveitis or evidence of past uveitis such as synechiae or keraticprecipitates in the study eye.
  9. Have an ocular neoplasm in the study eye.
  10. Have a clinically significant infection.
  11. 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.
  12. Use of systemic corticosteroids or NSAIDs in the seven days prior to surgery.
  13. Have a history of clinically significant corticosteroid-induced intraocular pressureincrease.
  14. Use of any medication for ocular hypertension or glaucoma in the study eye.
  15. Use of monoamine oxidase inhibitors for 21 days preoperatively.
  16. Prior participation in a clinical study of OMS302.
  17. Participating in any investigational drug or device trial within the 30 days prior tothe day of surgery.
  18. 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.
  19. Presence of any condition that the Investigator believes would put the subject at riskor confound the interpretation of the study data.
  20. 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

Total Participants: 78
Study Start date:
July 01, 2014
Estimated Completion Date:
September 12, 2016

Study 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.

Connect with a study center

  • Los Angeles, California 90027
    United States

    Site Not Available

  • Atlanta, Georgia 30322
    United States

    Site Not Available

  • Chicago, Illinois 60611
    United States

    Site Not Available

  • Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Kansas City, Kansas 66103
    United States

    Site Not Available

  • Boston, Massachusetts 02115
    United States

    Site Not Available

  • Detroit, Michigan 48201
    United States

    Site Not Available

  • Charleston, North Carolina 29425
    United States

    Site Not Available

  • Nashville, Tennessee 37232
    United States

    Site Not Available

  • Dallas, Texas 75390
    United States

    Site Not Available

  • Madison, Wisconsin 53705
    United States

    Site Not Available

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