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

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: NCT01605942
Recruitment Status : Terminated (Study terminated due to corporate decision.)
First Posted : May 25, 2012
Results First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Drug: Dexamethasone Drug Delivery System Drug: Placebo Drug Delivery System Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Medicines

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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): NCT01605942


Locations
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United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01605942    
Other Study ID Numbers: 206207-027
First Posted: May 25, 2012    Key Record Dates
Results First Posted: July 1, 2015
Last Update Posted: July 1, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Dexamethasone
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