Ocular InflammationPhase 2NCT03580473
Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
A Phase 2 study testing SATURNO II association and Vigadexa® in people with Ocular Inflammation and Cataract, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Inflammation, Cataract
- What is being tested?
- SATURNO II association and Vigadexa®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2020to 1 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- SATURNO II association, Vigadexa®
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SATURNO II associationDrug
Also called Legrand association
opthalmic solution, 4 times a day
Vigadexa®Drug
Also called Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL
opthalmic solution, 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| SATURNO II | Experimental | 1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery Receives: 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 Receives: Drug: Vigadexa® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 days
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start27 Feb 2020
- Primary completion30 Nov 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580473
- Sponsor's protocol ID
- EMS0118-SATURNO II
- Status last verified
- Mar 2022
- First submitted
- 23 May 2018
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03580473
- Acronym / sponsor ID
- EMS0118-SATURNO II
- Conditions
- Ocular Inflammation, Cataract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SATURNO II | Experimental | Drug: SATURNO II association1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery |
| Vigadexa® | Active comparator | Drug: Vigadexa®1 drop, 4 times a day, in the eye to be operated, 1 day before surgery until 15 days after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SATURNO II associationAlso: Legrand associationopthalmic solution, 4 times a day | Drug | SATURNO II |
| Vigadexa®Also: Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mLopthalmic solution, 4 times a day | Drug | Vigadexa® |
Primary outcome
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
Time frame: 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.
1 secondary outcome
Incidence and severity of adverse events recorded during the study
Time frame: 26 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SATURNO II association and Vigadexa® in people with Ocular Inflammation and Cataract, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.