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

Launched by EYEPOINT PHARMACEUTICALS, INC. · Jan 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called DEXYCU to see how safe it is for treating inflammation that can happen after cataract surgery in children. Cataract surgery helps improve vision by removing cloudy lenses from the eye, and this trial aims to ensure that DEXYCU can help manage any swelling or irritation that might occur afterwards.

To participate in this study, children who are having uncomplicated cataract surgery, with or without a lens implant, may be eligible. However, those with certain medical conditions or eye issues will not be able to join. If enrolled, participants will receive either DEXYCU or a standard treatment after their surgery, and doctors will monitor their recovery closely. This trial is currently looking for participants, and it could help improve care for children undergoing cataract surgery in the future.

Gender

ALL

Eligibility criteria

• 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