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

NCT ID: NCT01605942

Last Updated: 2015-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dexamethasone Drug Delivery System

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

Group Type EXPERIMENTAL

Dexamethasone Drug Delivery System

Intervention Type DRUG

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

Placebo Drug Delivery System

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

Group Type PLACEBO_COMPARATOR

Placebo Drug Delivery System

Intervention Type DRUG

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

Interventions

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Dexamethasone Drug Delivery System

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

Intervention Type DRUG

Placebo Drug Delivery System

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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206207-027

Identifier Type: -

Identifier Source: org_study_id

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