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

Sponsor
EMS (Industry)
Overall Status
Completed
CT.gov ID
NCT03580473
Collaborator
(none)
118
Enrollment
1
Location
2
Arms
24.1
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Feb 27, 2020
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber [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.

    Secondary Outcome Measures

    1. Incidence and severity of adverse events recorded during the study [26 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allegisa Campinas São Paulo Brazil 13.084-791

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT03580473
    Other Study ID Numbers:
    • EMS0118-SATURNO II
    First Posted:
    Jul 9, 2018
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Inflammation
    Moxifloxacin
    Dexamethasone
    Norgestimate, ethinyl estradiol drug combination

    Study Results

    No Results Posted as of Mar 7, 2022