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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 suspended participant recruitment.
(Pending availability of clinical supplies)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01605942
First received: May 23, 2012
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percent of Patients with Clearance of Anterior Chamber Inflammation [ Time Frame: Day 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of Patients Who are Pain Free [ Time Frame: Day 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the eye at the conclusion of cataract surgery
 Drug: Dexamethasone Drug Delivery System
Dexamethasone Drug Delivery System administered into the eye at the conclusion of cataract surgery
Placebo Comparator: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the eye at the conclusion of cataract surgery
 Drug: Placebo Drug Delivery System
Placebo Drug Delivery System administered into the eye at the conclusion of cataract surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605942

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

Additional Information:
More information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01605942     History of Changes
Other Study ID Numbers: 206207-027
Study First Received: May 23, 2012
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013