Back to resultsA Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Primary Purpose
Cataract
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Drug Delivery System
Placebo Drug Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone Drug Delivery System
Placebo Drug Delivery System
Arm Description
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Outcomes
Primary Outcome Measures
Number of Patients With Clearance of Anterior Chamber Inflammation
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
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01605942
Brief Title
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to corporate decision.
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Drug Delivery System
Arm Type
Experimental
Arm Description
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Arm Title
Placebo Drug Delivery System
Arm Type
Placebo Comparator
Arm Description
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Drug Delivery System
Intervention Description
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo Drug Delivery System
Intervention Description
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Primary Outcome Measure Information:
Title
Number of Patients With Clearance of Anterior Chamber Inflammation
Description
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).
Time Frame
Up to Day 71
Secondary Outcome Measure Information:
Title
Plasma Levels of Dexamethasone
Description
Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.
Time Frame
Day 2, Day 7, Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
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