DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 1, 2020

Detailed Description

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

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EyePoint Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dario Paggiarino, MD, Principal Investigator, Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals
    • Keyur Patel, PharmD, Study Chair, Vice President, Medical Affairs, EyePoint Pharmaceuticals
    • Flavio Leonin, Jr., MD, Study Director, Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals

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