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

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

Official Title
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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

Conditions
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Ocular Inflammation, Cataract

Intervention / Treatment
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* Drug: SATURNO II association
* Drug: Vigadexa®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study |  | 26 days |