DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Completed

• Conditions: Cataract
• Interventions: Drug: DEXYCU (dexamethasone intraocular suspension) 9%.

• Registration Number: NCT04290676
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

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%.

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-03-02
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Results First Submitted: 2021-04-06
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-24
• Last Update Submitted: 2021-05-24
• Results First Posted: 2021-05-26
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DEXYCU (dexamethasone intraocular suspension) 9%.	DEXYCU (dexamethasone intraocular suspension) 9%.	DEXYCU (dexamethasone intraocular suspension) 9%. Single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms).

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Anterior Chamber Cell Grade 0	Postoperative day 8	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.

Trial Locations

Locations (22)

Inland Eye Specialists; 🇺🇸 Hemet, California, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States

Coastal Vision Medical Group; 🇺🇸 Orange, California, United States

Physicians Eyecare Center; 🇺🇸 Baltimore, Maryland, United States

Surgery Center of Central New Jersey; 🇺🇸 Pennington, New Jersey, United States

Jacksoneye, SC; 🇺🇸 Lake Villa, Illinois, United States

Eye Center South Locations; 🇺🇸 Dothan, Alabama, United States

North Bay Eye Associates, Inc.; 🇺🇸 Rohnert Park, California, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States

Tekwani Vision Center; 🇺🇸 Saint Louis, Missouri, United States

Island Eye Surgicenter; 🇺🇸 Westbury, New York, United States

VRF Eye Specialty Group; 🇺🇸 Memphis, Tennessee, United States

SightMD, PLLC; 🇺🇸 Hauppauge, New York, United States

Discover Vision Centers; 🇺🇸 Independence, Missouri, United States

The Eye Centers of Racine and Kenosha; 🇺🇸 Racine, Wisconsin, United States

The Eye Associates of Manatee, LLP; 🇺🇸 Bradenton, Florida, United States

Wills Surgery Center; 🇺🇸 Jenkintown, Pennsylvania, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida; 🇺🇸 Largo, Florida, United States

Hauser-Ross Eye Institute; 🇺🇸 Oak Brook, Illinois, United States

New York Eye Surgery Center; 🇺🇸 Bronx, New York, United States

Valley Retina Institute, PA; 🇺🇸 McAllen, Texas, United States