InflammationPhase 3NCT01227876
Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery
A Phase 3 study testing Ster and Pred Fort in people with Inflammation and Cataract Surgery, run by Azidus Brasil at 1 site in Brazil.
Trial summary
Is the primary objective of this investigation to compare the clinical efficacy of the drug test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator - Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of postoperative inflammation in cataract surgery by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Cataract Surgery
- What is being tested?
- Ster and Pred Fort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 3
- 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
- Patients who agree with all study procedures and sign, by his own free will, IC;
- Adult patients, regardless of gender, ethnicity or social status, with good mental health;
- Patients who present at screening visit, a clinical diagnosis of cataract with an indication for corrective surgery with phacoemulsification technique.
Who cannot join
- Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;
- Patients with known hypersensitivity to any component of the drug under investigation;
- Patients who have made use of systemic corticosteroids within 15 days before surgery;
- Patients who have made use of topical corticosteroids in the 7 days before surgery;
- Patients who have made use of systemic antibiotics in the 15 days preceding surgery;
- Patients who have made use of topical antibiotics in the 7 days before surgery;
- Patients presenting abnormality, at the discretion of the principal investigator in the following ophthalmic examinations Preoperative slit-lamp examination, measurement of intraocular pressure (applanation tonometry) and examination of background, other than the underlying disease (cataract);
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery.
Is the primary objective of this investigation to compare the clinical efficacy of the drug test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator - Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of postoperative inflammation in cataract surgery by phacoemulsification through periodic measurement of efficiency scores (number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).
Read the detailed description
The secondary objective is to compare the safety data observed during the study period, ie will be assessed the frequency and intensity of adverse reactions and compared statistically between groups.
- Conditions
- Inflammation, Cataract Surgery
- Being tested
- Ster, Pred Fort
- Keywords
- PREUNI0710, cataract
- Medical subject headings
- Inflammation, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SterDrug
prednisolone 1% ophthalmic suspension
Pred FortDrug
prednisolone 1% ophthalmic suspension
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Ster ® (prednisolone 1% ophthalmic suspension - União Química) Receives: Drug: Ster |
| Comparator | Active comparator | Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan) Receives: Drug: Pred Fort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters.
We will evaluate the clinical parameters of number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds.The treatment will last for 28 days following the conduct of routine postoperative cataract. There will be a total of 04 returns after surgery and with them 07, 14, 21 and 28 days. On each return, will register the change of parameters of efficacy and safety.
Measured: 28 days of treatment.
Secondary outcomes (1)
Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.
The treatment will last for 28 days following the conduct of routine postoperative cataract. There will be a total of 04 returns after surgery and with them 07, 14, 21 and 28 days. On each return, will register the change of parameters of efficacy and safety.
Measured: 28 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227876
- Sponsor's protocol ID
- PREUNI0710
- Other IDs
- Version 01
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2010
- Last updated
- 2 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery.
- ClinicalTrials.gov ID
- NCT01227876
- Acronym / sponsor ID
- PREUNI0710
- Conditions
- Inflammation, Cataract Surgery
- Keywords
- PREUNI0710, cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- 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.
Is the primary objective of this investigation to compare the clinical efficacy of the drug test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator - Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of postoperative inflammation in cataract surgery by phacoemulsification through periodic measurement of efficiency scores (number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).
Detailed description
The secondary objective is to compare the safety data observed during the study period, ie will be assessed the frequency and intensity of adverse reactions and compared statistically between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: SterSter ® (prednisolone 1% ophthalmic suspension - União Química) |
| Comparator | Active comparator | Drug: Pred FortPred Fort ® (prednisolone 1% ophthalmic suspension - Allergan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who agree with all study procedures and sign, by his own free will, IC;
Key exclusion criteria (8 listed)
- Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;
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 |
|---|---|---|
| Sterprednisolone 1% ophthalmic suspension | Drug | Test |
| Pred Fortprednisolone 1% ophthalmic suspension | Drug | Comparator |
Primary outcome
Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters.
Time frame: 28 days of treatment.
We will evaluate the clinical parameters of number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds.The treatment will last for 28 days following the conduct of routine postoperative cataract. There will be a total of 04 returns after surgery and with them 07, 14, 21 and 28 days. On each return, will register the change of parameters of efficacy and safety.
1 secondary outcome
Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.
Time frame: 28 days of treatment.
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 2 Nov 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 3 study testing Ster and Pred Fort in people with Inflammation and Cataract Surgery, run by Azidus Brasil 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 3 inclusion and 8 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 2 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters. (time frame: 28 days of treatment.). 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 2 Nov 2022.