A Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

  • STATUS
    Recruiting
  • End date
    Feb 11, 2024
  • participants needed
    60
  • sponsor
    EyePoint Pharmaceuticals, Inc.
Updated on 4 October 2022
prednisolone
dexamethasone
intraocular lens implantation
posterior chamber intraocular lens

Summary

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

Details
Condition Cataract
Treatment Dexamethasone, Prednisolone Acetate Ophthalmic
Clinical Study IdentifierNCT05191706
SponsorEyePoint Pharmaceuticals, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content)
Other protocol-specified inclusion criteria may apply

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
Has a post-traumatic cataract
Presence of active or suspected viral, bacterial, or fungal disease in the study eye
Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy
Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening
Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time
Other protocol-specified exclusion criteria may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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