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

January 12, 2021 updated by: iDrop, Inc.

A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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

  • El Salvador
      • San Salvador, El Salvador
        • Centre De. Oftalmologia

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:

  • Patients undergoing traditional cataract surgery.

Exclusion Criteria:

  • Patients with unusual ocular conditions.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexamethasone Dose 1
Drug: Dexamethasone Dose 1
Dexamethasone ophthalmic suspension dose 1
ACTIVE_COMPARATOR: Dexamethasone Dose 2
Drug: Dexamethasone Dose 2
Dexamethasone ophthalmic suspension dose 2
PLACEBO_COMPARATOR: Placebo Dose 1
Drug: Placebo Dose 1
Placebo suspension dose 1
PLACEBO_COMPARATOR: Placebo Dose 2
Drug: Placebo Dose 2
Placebo suspension dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular inflammation
Time Frame: Day 8
Measuring Anterior Cell Count
Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Pain
Time Frame: Day 8
Measuring patient ocular pain using an 11-point visual scale
Day 8

Collaborators and Investigators

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

Sponsor

iDrop, Inc.

Investigators

  • Principal Investigator: Gabriel Casada, MD, President - Centre De. Oftalmolgia

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)

September 14, 2020

Primary Completion (ACTUAL)

October 31, 2020

Study Completion (ACTUAL)

November 15, 2020

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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