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OpenTrials
Completed

NCT Number: NCT04711213

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

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.

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Key information

Conditions

Cataract in Inflammatory Ocular Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre De. Oftalmologia

San Salvador, El Salvador

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing traditional cataract surgery.

Exclusion criteria

  • Patients with unusual ocular conditions.

Treatment and study plan

Dexamethasone Dose 1

Drug

Dexamethasone ophthalmic suspension dose 1

Dexamethasone Dose 2

Drug

Dexamethasone ophthalmic suspension dose 2

Placebo Dose 1

Drug

Placebo suspension dose 1

Placebo Dose 2

Drug

Placebo suspension dose 2

Primary outcomes

  1. Ocular inflammation

    Time frame: Day 8

    Measuring Anterior Cell Count

Secondary outcomes

  1. Ocular Pain

    Time frame: Day 8

    Measuring patient ocular pain using an 11-point visual scale

Sponsors and collaborators

Lead sponsor

iDrop, Inc.

Industry

Registry information

Official study title

A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.