Clinical trial NCT05191706: Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cataract
Keywords: pediatric
cataract
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 60
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Grade of anterior chamber cells (ACC)
timeFrame: Post-Operative Day 14
Secondary outcomes:
measure: Grade of anterior chamber flare (ACF)
timeFrame: Post-Operative Day 14
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: EyePoint Investigational Site
state: California
city: Palo Alto
country: United States
facility: EyePoint Investigational Site
state: California
city: Boston
country: United States
facility: EyePoint Investigative Site
state: Massachusetts
city: Jackson
country: United States
facility: EyePoint Investigational Site
state: Mississippi
city: Omaha
country: United States
facility: EyePoint Investigational Site
state: Nebraska
city: Buffalo
country: United States
facility: EyePoint Investigational Site
state: New York
city: New York
country: United States
facility: EyePoint Investigative Site
state: New York
city: Rochester
country: United States
facility: EyePoint Investigational Site
state: New York
city: Charleston
country: United States
facility: EyePoint Investigational Site
state: South Carolina
Study officials:
References: