Back to resultsEfficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
Primary Purpose
Ocular Inflammation, Cataract
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
SATURNO II association
Vigadexa®
Sponsored by
About this trial
This is an interventional prevention trial for Ocular Inflammation
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.
Sites / Locations
- Allegisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SATURNO II
Vigadexa®
Arm Description
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03580473
Brief Title
Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation, Cataract
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SATURNO II
Arm Type
Experimental
Arm Description
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
Arm Title
Vigadexa®
Arm Type
Active Comparator
Arm Description
1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery
Intervention Type
Drug
Intervention Name(s)
SATURNO II association
Other Intervention Name(s)
Legrand association
Intervention Description
opthalmic solution, 4 times a day
Intervention Type
Drug
Intervention Name(s)
Vigadexa®
Other Intervention Name(s)
Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL
Intervention Description
opthalmic solution, 4 times a day
Primary Outcome Measure Information:
Title
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
Description
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.
Time Frame
16 days
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study
Time Frame
26 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Allegisa
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13.084-791
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
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