Study Stopped
Study terminated due to corporate decision.
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
July 1, 2015
CompletedJuly 1, 2015
June 1, 2015
3 months
May 23, 2012
June 11, 2015
June 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Up to Day 71
Secondary Outcomes (1)
Plasma Levels of Dexamethasone
Day 2, Day 7, Day 14
Study Arms (2)
Dexamethasone Drug Delivery System
EXPERIMENTALDexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Placebo Drug Delivery System
PLACEBO COMPARATORPlacebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Planned single cataract extraction with lens implant
- Best-corrected visual acuity of 20/200 or better in the opposite eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Newport Beach, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 25, 2012
Study Start
June 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 1, 2015
Results First Posted
July 1, 2015
Record last verified: 2015-06