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A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery

This study has been terminated.
(Study terminated due to corporate decision.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605942
First Posted: May 25, 2012
Last Update Posted: July 1, 2015
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.
Information provided by (Responsible Party):
Allergan
  Purpose
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.

Condition Intervention Phase
Cataract Drug: Dexamethasone Drug Delivery System Drug: Placebo Drug Delivery System Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Patients With Clearance of Anterior Chamber Inflammation [ Time Frame: Up to Day 71 ]
    The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).


Secondary Outcome Measures:
  • Plasma Levels of Dexamethasone [ Time Frame: Day 2, Day 7, Day 14 ]
    Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.


Enrollment: 8
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Comparator: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Drug: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned single cataract extraction with lens implant
  • Best-corrected visual acuity of 20/200 or better in the opposite eye

Exclusion Criteria:

  • Glaucoma or history of intraocular hypertension in the study eye
  • History of chronic ocular allergy in the last year requiring treatment
  • Scheduled for cataract surgery in the non-study eye during study participation
  Contacts and Locations
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): NCT01605942


Locations
United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01605942     History of Changes
Other Study ID Numbers: 206207-027
First Submitted: May 23, 2012
First Posted: May 25, 2012
Results First Submitted: June 11, 2015
Results First Posted: July 1, 2015
Last Update Posted: July 1, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
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