NCT05191706 · EyePoint Pharmaceuticals, Inc.
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
What this study is about
A Phase 3/4, forward-looking, randomly assigned, Active Treatment-Controlled, Parallel-Design, conducted at multiple hospitals Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
View original scientific description
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
Interventions
DRUG
Dexamethasone
single anterior chamber injection
DRUG
Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper
Primary outcome measures
Grade of anterior chamber cells (ACC)
Time frame: Post-Operative Day 14
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Scree
Where
- Huntington Beach, California
- Palo Alto, California
- Boston, Massachusetts
- Jackson, Mississippi
- Omaha, Nebraska
- Buffalo, New York
- New York, New York
- Rochester, New York
- Charleston, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2025 · Source of record for eligibility and locations