A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

iDrop, Inc.60 enrolled

Overview

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cataract in Inflammatory Ocular Disorders

Interventions

Dexamethasone Dose 1DRUG

Dexamethasone ophthalmic suspension dose 1

Dexamethasone Dose 2DRUG

Dexamethasone ophthalmic suspension dose 2

Placebo Dose 1DRUG

Placebo suspension dose 1

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing traditional cataract surgery. Exclusion Criteria: * Patients with unusual ocular conditions.

Locations (1)

Centre De. Oftalmologia

San Salvador, El Salvador

Outcomes

Primary Outcomes

Ocular inflammation

Measuring Anterior Cell Count

Time frame: Day 8

Secondary Outcomes

Ocular Pain

Measuring patient ocular pain using an 11-point visual scale

Time frame: Day 8

Data from ClinicalTrials.gov

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