EYP-DIP-001: A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

About this Study

The purpose of this study is to test the safety of an investigational drug product, (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery.

Sponsor Protocol ID:EYP-DIP-001
IRB Number:2021V0822
Actively Enrolling
Phase 3
October 04, 2022
Eligibility Criteria
3 years old
Both Male and Female

Inclusion Criteria
  • Parent/legal guardian must sign Informed Consent Form 
  • Male or female
  • 0 to 3 years of age
  • Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation
  • If a contact lens is used for correction of post-operative, it must be either a silicone elastomer lens or a rigid gas permeable lens

Exclusion Criteria
  • 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 of suspected viral, bacterial, or fungal disease in the study eye
  • Have a post-traumatic cataract
  • Have an ocular neoplasm in the study eye
  • Have suspected permanent or low vision in the fellow non-study eye, unless caused by a cataract
  • Use of any ocular, topical, or oral corticosteroids within 7 days prior to Day 0
  • Periocular corticosteroid injection in the study eye in the 3 months prior to Screening
  • Received any intravitreal corticosteroid delivery vehicle in the study eye at any time.
  • Requiring treatment with any corticosteroids by any route, except inhalation, during the study
  • Known allergy or hypersensitivity to dexamethasone and/or prednisolone
  • Prior intraocular surgery in the study eye
  • Planned intraocular or laser surgery in the study eye at any point during the study
  • Any signs of intraocular inflammation in either eye at Screening

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Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Grants Ferry - UMMC
Lakeland Medical - UMMC
Contact Information
Contact Name: Morgan Ladner
Phone Number: 601-984-5046
Email: mladner@umc.edu
Principal Investigator:HongVan Le
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