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DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 (DEXYCURetro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290676
Recruitment Status : Completed
First Posted : March 2, 2020
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
EyePoint Pharmaceuticals, Inc.

Study Description
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Brief Summary:
Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Condition or disease Intervention/treatment
Cataract Drug: 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 Design
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Study Type : Observational
Actual Enrollment : 527 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 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).
Other Name: dexamethasone intraocular suspension


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290676


Locations
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Sponsors and Collaborators
EyePoint Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Dario Paggiarino, MD Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals
Study Chair: Keyur Patel, PharmD Vice President, Medical Affairs, EyePoint Pharmaceuticals
Study Director: Flavio Leonin, Jr., MD Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by EyePoint Pharmaceuticals, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] October 15, 2019

More Information
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Responsible Party: EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04290676    
Other Study ID Numbers: DEXYCU Retrospective Study 001
First Posted: March 2, 2020    Key Record Dates
Results First Posted: May 26, 2021
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by EyePoint Pharmaceuticals, Inc.:
DEXYCU
Cataract
dexamethasone intraocular suspension
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action