Clinical trial NCT04290676: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
Official title: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: DEXYCU
Cataract
dexamethasone intraocular suspension
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-02
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Brief summary: Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Detailed description: This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Eligibility criteria: Inclusion Criteria

* Male and Female subjects at least 18 years of age
* Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Exclusion Criteria

• Subjects who underwent cataract surgery and did not receive DEXYCU

Primary outcomes:
measure: Percentage of Eyes With Anterior Chamber Cell Grade 0
timeFrame: Postoperative day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South Locations
state: Alabama
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Orange
country: United States
facility: Coastal Vision Medical Group
state: California
city: Rohnert Park
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Bradenton
country: United States
facility: The Eye Associates of Manatee, LLP
state: Florida
city: Largo
country: United States
facility: Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida
state: Florida
city: Lake Villa
country: United States
facility: Jacksoneye, SC
state: Illinois
city: Oak Brook
country: United States
facility: Hauser-Ross Eye Institute
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Baltimore
country: United States
facility: Physicians Eyecare Center
state: Maryland
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Pennington
country: United States
facility: Surgery Center of Central New Jersey
state: New Jersey
city: Bronx
country: United States
facility: New York Eye Surgery Center
state: New York
city: Hauppauge
country: United States
facility: SightMD, PLLC
state: New York
city: Westbury
country: United States
facility: Island Eye Surgicenter
state: New York
city: Jenkintown
country: United States
facility: Wills Surgery Center
state: Pennsylvania
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals
name: Dario Paggiarino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vice President, Medical Affairs, EyePoint Pharmaceuticals
name: Keyur Patel, PharmD
role: STUDY_CHAIR
affiliation: Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals
name: Flavio Leonin, Jr., MD
role: STUDY_DIRECTOR
References: