MedTrace Logo

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

NCT04711213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Cataract in Inflammatory Ocular Disorders

Interventions

DRUG

Dexamethasone Dose 1

Dexamethasone ophthalmic suspension dose 1

DRUG

Dexamethasone Dose 2

Dexamethasone ophthalmic suspension dose 2

DRUG

Placebo Dose 1

Placebo suspension dose 1

DRUG

Placebo Dose 2

Placebo suspension dose 2

Sponsors & Collaborators

  • iDrop, Inc.

    lead INDUSTRY

Principal Investigators

  • Gabriel Casada, MD · President - Centre De. Oftalmolgia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2020-10-31
Completion
2020-11-15
FDA Drug
Yes

Countries

  • El Salvador

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711213 on ClinicalTrials.gov