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OpenTrials
Completed

NCT Number: NCT03687931

A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

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

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Key information

Conditions

Inflammation Eye Endophthalmitis Eye Diseases Eye Infections Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Arizona Eye Center

Chandler, Arizona, 85224, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion criteria

  • Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
  • Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
  • Patients who are known steroid responders

Treatment and study plan

Dexamethasone

Drug

Drop

Primary outcomes

  1. Anterior Chamber Cell

    Time frame: 30 days

    Number of cells in the anterior chamber

Sponsors and collaborators

Lead sponsor

iDrop, Inc.

Industry

Registry information

Official study title

A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2018
Registry last updated
May 24, 2019

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.

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