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

Phase 1TerminatedNCT01605942

Allergan8 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cataract

Interventions

Dexamethasone Drug Delivery SystemDRUG

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

Placebo Drug Delivery SystemDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Newport Beach, California, United States

Outcomes

Primary Outcomes

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).

Time frame: Up to Day 71

Secondary Outcomes

Plasma Levels of Dexamethasone

Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.

Time frame: Day 2, Day 7, Day 14

Data from ClinicalTrials.gov

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