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

Phase 1

Terminated

• Conditions: Cataract
• Interventions: Drug: Placebo Drug Delivery System; Drug: Dexamethasone Drug Delivery System

• Registration Number: NCT01605942
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Study Start: 2012-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-06
• Results First Submitted: 2015-06-11
• Results First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Results First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Planned single cataract extraction with lens implant
• Best-corrected visual acuity of 20/200 or better in the opposite eye

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Drug Delivery System	Placebo Drug Delivery System	Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
Dexamethasone Drug Delivery System	Dexamethasone Drug Delivery System	Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clearance of Anterior Chamber Inflammation	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

Name	Time	Method
Plasma Levels of Dexamethasone	Day 2, Day 7, Day 14	Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.