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

NCT ID: NCT03580473

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2022-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

SATURNO II

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

Group Type: EXPERIMENTAL

SATURNO II association

Intervention Type: DRUG

opthalmic solution, 4 times a day

Vigadexa®

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

Group Type: ACTIVE_COMPARATOR

Vigadexa®

Intervention Type: DRUG

opthalmic solution, 4 times a day

Interventions

SATURNO II association

opthalmic solution, 4 times a day

Intervention Type: DRUG

Vigadexa®

opthalmic solution, 4 times a day

Intervention Type: DRUG

Other Intervention Names

Legrand association; Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allegisa

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EMS0118-SATURNO II

Identifier Type: -

Identifier Source: org_study_id