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

NCT ID: NCT04711213

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2020-11-15

Brief Summary

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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.

Detailed Description

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

Conditions

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Cataract in Inflammatory Ocular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized to 2 active dosing groups and 2 corresponding dosing groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single Masked randomized study

Study Groups

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Dexamethasone Dose 1

Group Type ACTIVE_COMPARATOR

Dexamethasone Dose 1

Intervention Type DRUG

Dexamethasone ophthalmic suspension dose 1

Dexamethasone Dose 2

Group Type ACTIVE_COMPARATOR

Dexamethasone Dose 2

Intervention Type DRUG

Dexamethasone ophthalmic suspension dose 2

Placebo Dose 1

Group Type PLACEBO_COMPARATOR

Placebo Dose 1

Intervention Type DRUG

Placebo suspension dose 1

Placebo Dose 2

Group Type PLACEBO_COMPARATOR

Placebo Dose 2

Intervention Type DRUG

Placebo suspension dose 2

Interventions

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Dexamethasone Dose 1

Dexamethasone ophthalmic suspension dose 1

Intervention Type DRUG

Dexamethasone Dose 2

Dexamethasone ophthalmic suspension dose 2

Intervention Type DRUG

Placebo Dose 1

Placebo suspension dose 1

Intervention Type DRUG

Placebo Dose 2

Placebo suspension dose 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing traditional cataract surgery.

Exclusion Criteria

* Patients with unusual ocular conditions.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iDrop, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Casada, MD

Role: PRINCIPAL_INVESTIGATOR

President - Centre De. Oftalmolgia

Locations

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Centre De. Oftalmologia

San Salvador, , El Salvador

Site Status

Countries

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El Salvador

Other Identifiers

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C-02

Identifier Type: -

Identifier Source: org_study_id

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