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

Allergan

Status and phase: Terminated; Phase 1

Conditions: Cataract

Treatments: Drug: Placebo Drug Delivery System; Drug: Dexamethasone Drug Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01605942

206207-027

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups, including a placebo group

Dexamethasone Drug Delivery System

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone Drug Delivery System

Placebo Drug Delivery System

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Drug Delivery System