DEXYCU for Post-Surgical Inflammation in Childhood Cataract
Trial Summary
What is the purpose of this trial?
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
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have received certain corticosteroid treatments in the study eye recently, you may not be eligible.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the idea that DEXYCU for Post-Surgical Inflammation in Childhood Cataract is an effective treatment?
The available research shows that DEXYCU, a form of dexamethasone, is effective in managing inflammation after cataract surgery. In a study comparing DEXYCU with prednisolone acetate eye drops, DEXYCU was found to be effective in reducing inflammation. Another study on a similar dexamethasone treatment (Dextenza) showed that it reduced or eliminated the need for additional steroid drops in children after cataract surgery. This suggests that DEXYCU can be a good option for managing post-surgical inflammation in childhood cataract.12345
What data supports the effectiveness of the drug DEXYCU for reducing post-surgical inflammation in childhood cataract?
What safety data is available for DEXYCU in treating post-surgical inflammation in childhood cataract?
DEXYCU, a dexamethasone intraocular suspension, is FDA-approved for postoperative inflammation and provides sustained release of medication. Safety data from various studies indicate that it is effective in reducing inflammation with a controlled release mechanism. In a study involving pediatric cataract surgery, 18% of eyes experienced a spike in intraocular pressure, and 29% required additional topical steroids. Another study compared DEXYCU with prednisolone acetate drops, highlighting its safety and efficacy. Overall, DEXYCU minimizes contact with sensitive eye tissues and allows for controlled drug delivery, enhancing safety and efficiency.12567
Is DEXYCU safe for treating post-surgical inflammation in children with cataracts?
Is the drug Dexamethasone a promising treatment for post-surgical inflammation in childhood cataract?
How is the drug DEXYCU different from other treatments for post-surgical inflammation in childhood cataract?
DEXYCU is unique because it is a single-dose, sustained-release steroid injected directly into the eye during surgery, which reduces the need for daily eye drops and ensures the medication is delivered precisely where needed. This method allows for better control by the surgeon and minimizes the reliance on patient compliance with eye drop regimens.15678
Eligibility Criteria
This trial is for children undergoing routine cataract surgery, with or without lens implantation. Participants must not have post-traumatic cataracts, eye infections, high eye pressure over 25 mmHg even with treatment, or recent corticosteroid injections in the eye. They should also be free of major health issues that could increase risks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a single injection of DEXYCU or prednisolone acetate ophthalmic suspension for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexamethasone
- Prednisolone Acetate Ophthalmic
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
EyePoint Pharmaceuticals, Inc.
Lead Sponsor