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

NCT03580473 | Completed Phase 2 DMC

• 1 other identifier: EMS0118-SATURNO II
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ocular Inflammation; Cataract

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Incidence and severity of adverse events recorded during the study

  26 days

Study Arms (2)

SATURNO II

EXPERIMENTAL

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

Vigadexa®

ACTIVE COMPARATOR

1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery

Drug: Vigadexa®

Interventions

SATURNO II association DRUG

opthalmic solution, 4 times a day

Also known as: Legrand association

SATURNO II

Vigadexa® DRUG

opthalmic solution, 4 times a day

Also known as: Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL

Vigadexa®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Location

MeSH Terms

Conditions

Cataract

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: July 9, 2018
• Study Start: February 27, 2020
• Primary Completion: November 30, 2021
• Study Completion: March 1, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

BR (1)