Clinical trial NCT04539548: A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Official title: A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Dextenza, dexamethasone ophthalmic insert
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 65
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Detailed description: Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

Eligibility criteria: Inclusion Criteria:

* Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is \>5 years of age)
* Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Has ocular hypertension (defined as IOP of \>21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
* Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye

Primary outcomes:
measure: Adverse Events
timeFrame: Up to approximately 42 days after surgery
measure: Subject FLACC Pain Assessment
timeFrame: From screening through day 42
measure: IOP
timeFrame: From screening, then day 2 through 42
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Ocular Therapeutix
state: Colorado
city: Fort Collins
country: United States
facility: Ocular Therapeutix
state: Colorado
city: Jacksonville
country: United States
facility: Ocular Therapeutix
state: Florida
city: Indianapolis
country: United States
facility: Ocular Therapeutix
state: Indiana
city: Lexington
country: United States
facility: Ocular Therapeutix
state: Kentucky
city: Boston
country: United States
facility: Ocular Therapeutix
state: Massachusetts
city: Minneapolis
country: United States
facility: Ocular Therapeutix
state: Minnesota
city: Rochester
country: United States
facility: Ocular Therapeutix
state: Minnesota
city: Saint Louis
country: United States
facility: Ocular Therapeutix
state: Missouri
city: Erie
country: United States
facility: Ocular Therapeutix
state: Pennsylvania
city: Charleston
country: United States
facility: Ocular Therapeutix
state: South Carolina
city: Nashville
country: United States
facility: Ocular Therapeutix
state: Tennessee
city: Virginia Beach
country: United States
facility: Ocular Therapeutix
state: Virginia
city: Madison
country: United States
facility: Ocular Therapeutix
state: Wisconsin
Study officials:
References: