DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Cataract Clinical Trial

— DEXYCURetro  

Official title:

DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290676
• Other study ID #: DEXYCU Retrospective Study 001
• Status: Completed
• Start date: November 13, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2021
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• DEXYCU (dexamethasone intraocular suspension) 9%.
DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).

Locations

Country	Name	City	State
United States	Physicians Eyecare Center	Baltimore	Maryland
United States	The Eye Associates of Manatee, LLP	Bradenton	Florida
United States	New York Eye Surgery Center	Bronx	New York
United States	Eye Center South Locations	Dothan	Alabama
United States	SightMD, PLLC	Hauppauge	New York
United States	Inland Eye Specialists	Hemet	California
United States	Discover Vision Centers	Independence	Missouri
United States	Price Vision Group	Indianapolis	Indiana
United States	Wills Surgery Center	Jenkintown	Pennsylvania
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Harvard Eye Associates	Laguna Hills	California
United States	Jacksoneye, SC	Lake Villa	Illinois
United States	Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida	Largo	Florida
United States	Valley Retina Institute, PA	McAllen	Texas
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	Hauser-Ross Eye Institute	Oak Brook	Illinois
United States	Coastal Vision Medical Group	Orange	California
United States	Surgery Center of Central New Jersey	Pennington	New Jersey
United States	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	North Bay Eye Associates, Inc.	Rohnert Park	California
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Island Eye Surgicenter	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With Anterior Chamber Cell Grade 0	Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam.	Postoperative day 8