Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification

March 4, 2022 updated by: EMS

Phase II, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification

The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

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

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13.084-791
        • Allegisa

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants of both sexes, aged 18 years or more;
  • Participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure;
  • Participants who undergo surgery in only 1 eye at a time;
  • Participants with intraocular pressure (IOP) ≤ 20 mmHg;
  • Signed consent.

Exclusion Criteria:

  • Used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial;
  • Performing the surgery for the second time, to correct the previous procedure or to change the lens;
  • Decompensated glaucoma or ocular hypertension with IOP above 21 mmHg;
  • Active ocular infectious diseases;
  • History hypersensitivity to the active ingredients used in the study;
  • Pregnancy or risk of pregnancy and lactating patients;
  • History alcohol abuse or illicit drug use;
  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
  • Participation in clinical trial in the year prior to this study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SATURNO II
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
Drug: SATURNO II association
opthalmic solution, 4 times a day
Other Names:
  • Legrand association
Active Comparator: Vigadexa®
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
Drug: Vigadexa®
opthalmic solution, 4 times a day
Other Names:
  • Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
Time Frame: 16 days
The inflammation will be evaluated though the presence of cells in the anterior chamber. For this, the number of cells per high-power field in the anterior chamber was counted and recorded on a scale where 0 indicates ≤ 5 cells, 1 = 5 to 10 cells, 2 = 11 to 20 cells, 3 = 21 to 50 cells, and 4 corresponds to ≥ 50 cells.
16 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study
Time Frame: 26 days
26 days

Collaborators and Investigators

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

Sponsor

EMS

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)

February 27, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

May 23, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0118-SATURNO II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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