DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Center South Locations, Dothan, Alabama, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEXYCU (dexamethasone intraocular suspension) 9%.

Drug

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).

Other names: dexamethasone intraocular suspension

Primary outcomes

Percentage of Eyes With Anterior Chamber Cell Grade 0

Time frame: 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.

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Acronym: DEXYCURetro

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Mar 2, 2020
Registry last updated: May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed