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

  • Post-Operative Outcome (anti-inflammatory efficacy – Intraocular Pressure)
    • Time Frame: Post-Operative at Day 1
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome tolerability – Product Tolerated [surgical complications questionnaire (e.g., Bleed, Use of Iris Hook, Other, None)]
    • Time Frame: Post-Operative at Day 1
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome intraocular behavior of the product – Rank Efficacy vs. Topical Steroid Grading Scale (e.g., Superior, Comparable, Not Recorded)
    • Time Frame: Post-Operative at Day 1
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome (anti-inflammatory efficacy – Intraocular Pressure)
    • Time Frame: Post-Operative at Day 8
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome Product Tolerated [surgical complications questionnaire (e.g., Bleed, Use of Iris Hook, Other, None)]
    • Time Frame: Post-Operative at Day 8
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome intraocular behavior of the product – Rank Efficacy vs. Topical Steroid Grading Scale (e.g., Superior, Comparable, Not Recorded)
    • Time Frame: Post-Operative at Day 8
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome (anti-inflammatory efficacy – Intraocular Pressure)
    • Time Frame: Post-Operative at Day 14
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome Product Tolerated [surgical complications questionnaire (e.g., Bleed, Use of Iris Hook, Other, None)]
    • Time Frame: Post-Operative at Day 14
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome intraocular behavior of the product – Rank Efficacy vs. Topical Steroid Grading Scale (e.g., Superior, Comparable, Not Recorded)
    • Time Frame: Post-Operative at Day 14
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome (anti-inflammatory efficacy – Intraocular Pressure)
    • Time Frame: Post-Operative at Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome Product Tolerated [surgical complications questionnaire (e.g., Bleed, Use of Iris Hook, Other, None)]
    • Time Frame: Post-Operative at Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome intraocular behavior of the product – Rank Efficacy vs. Topical Steroid Grading Scale (e.g., Superior, Comparable, Not Recorded)
    • Time Frame: Post-Operative at Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome (anti-inflammatory efficacy – Intraocular Pressure)
    • Time Frame: Post-Operative Day: Unscheduled up to Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome Product Tolerated [surgical complications questionnaire (e.g., Bleed, Use of Iris Hook, Other, None)]
    • Time Frame: Post-Operative Day: Unscheduled up to Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Post-Operative Outcome intraocular behavior of the product – Rank Efficacy vs. Topical Steroid Grading Scale (e.g., Superior, Comparable, Not Recorded)DEXYCU vs. Topical Steroid)
    • Time Frame: Post-Operative Day: Unscheduled up to Day 30
    • Post-Operative Cataract Assessments after the use of DEXYCU
  • Patient Satisfaction Questionnaire with DEXYCU (Based on feedback to the Surgeon)
    • Time Frame: Post-Operative up to Day 30
    • Patient satisfaction after the use of DEXYCU.
  • Surgeon Satisfaction Questionnaire with DEXYCU (Questions include: Ease of use, Postoperative regimen, DEXYCU time efficiency for physicians and staff)
    • Time Frame: Post-Operative up to Day 30
    • Surgeon satisfaction after the use of DEXYCU.

Secondary Measures

  • Unanticipated reportable adverse events
    • Time Frame: Post-Operative at Day 1
    • Unanticipated events related to DEXYCU.
  • Unanticipated reportable adverse events
    • Time Frame: Post-Operative at Day 8
    • Unanticipated events related to DEXYCU.
  • Unanticipated reportable adverse events
    • Time Frame: Post-Operative at Day 14
    • Unanticipated events related to DEXYCU.
  • Unanticipated reportable adverse events
    • Time Frame: Post-Operative at Day 30
    • Unanticipated events related to DEXYCU.
  • Unanticipated reportable adverse events
    • Time Frame: Post-Operative Day: Unscheduled up to Day 30
    • Unanticipated events related to DEXYCU.

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
  • 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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