Prednisolone Acetate Ophthalmic: topical administration four times a day for 28 days, followed by treatment taper
Study 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
Sex
ALL
Min age
—
Max age
3 Years
Healthy volunteers
No
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 outcome measure(s)
Grade of anterior chamber cells (ACC) — Post-Operative Day 14
Trial sites (9)
Facility
City
Region
Status
EyePoint Investigational Site
Huntington Beach
California
Recruiting
EyePoint Investigational Site
Palo Alto
California
Active Not Recruiting
EyePoint Investigative Site
Boston
Massachusetts
Recruiting
EyePoint Investigational Site
Jackson
Mississippi
Recruiting
EyePoint Investigational Site
Omaha
Nebraska
Recruiting
EyePoint Investigational Site
Buffalo
New York
Recruiting
EyePoint Investigative Site
New York
New York
Recruiting
EyePoint Investigational Site
Rochester
New York
Recruiting
EyePoint Investigational Site
Charleston
South Carolina
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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