NCT01605942TerminatedPhase 1
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Allergan
- Enrollment
- 8
- Primary Endpoint
- Number of Patients With Clearance of Anterior Chamber Inflammation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Drug Delivery System
Placebo Comparator
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Intervention: Placebo Drug Delivery System (Drug)
Dexamethasone Drug Delivery System
Experimental
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Intervention: Dexamethasone Drug Delivery System (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Plasma Levels of Dexamethasone(Day 2, Day 7, Day 14)
Investigators
Similar Trials
Completed
Phase 3
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)Macular EdemaNCT01660802Allergan262
Completed
Phase 3
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the RetinaMacular EdemaNCT04976777AbbVie54
Completed
Phase 2
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)Choroidal NeovascularizationAge-Related MaculopathyNCT00511706Allergan243
Completed
Phase 1
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein OcclusionMacular DegenerationMacular EdemaBranch Retinal Vein OcclusionNCT00308477Sanwa Kagaku Kenkyusho Co., Ltd.
Completed
Phase 3
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular EdemaDiabetic Macular EdemaNCT00168337Allergan554