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

May 23, 2019 updated by: iDrop, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Dexamethasone suspension dose level 1
Drug: Dexamethasone
Drop
Experimental: Arm 2
Dexamethasone suspension dose level 2
Drug: Dexamethasone
Drop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior Chamber Cell
Time Frame: 30 days
Number of cells in the anterior chamber
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iDrop, Inc.

Investigators

  • Study Chair: William White, iDrop, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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