RECRUITINGPhase 4INTERVENTIONAL
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
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
About 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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Dexamethasone
single anterior chamber injection
DRUG
Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper
Locations (9)
EyePoint Investigational Site
Huntington Beach, California, United States
EyePoint Investigational Site
Palo Alto, California, United States
EyePoint Investigative Site
Boston, Massachusetts, United States
EyePoint Investigational Site
Jackson, Mississippi, United States
EyePoint Investigational Site
Omaha, Nebraska, United States
EyePoint Investigational Site
Buffalo, New York, United States
EyePoint Investigative Site
New York, New York, United States
EyePoint Investigational Site
Rochester, New York, United States
EyePoint Investigational Site
Charleston, South Carolina, United States