Ocular Infection and InflammationPhase 3NCT01218737
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
A Phase 3 study testing 0.3% gatifloxacin and 1.0% prednisolone acetate association and isolated 0.3% gatifloxacin and 1.0% prednisolone acetate in people with Ocular Infection and Inflammation, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Infection and Inflammation
- What is being tested?
- 0.3% gatifloxacin and 1.0% prednisolone acetate association and isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jun 2009
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
- Patient presents a normal eye fundus.
- Patient has intraocular pressure (IOP) ≤ 20 mmHg.
Who cannot join
- Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
- Patient has diabetes or is immunodepressed.
- Any systemic infection during the study.
- Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
- Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
- Patient has known hypersensitivity to any of the components of the formulations used in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Dept of Ophthalmology
São Paulo, São Paulo, 04023-062
About this study
Official title: Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
- Conditions
- Ocular Infection and Inflammation
- Being tested
- 0.3% gatifloxacin and 1.0% prednisolone acetate association, isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
- Medical subject headings
- Eye Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% gatifloxacin and 1.0% prednisolone acetate associationDrug
Also called Zypred
Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
isolated 0.3% gatifloxacin and 1.0% prednisolone acetateDrug
Also called Zymar, Pred Fort
Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15.
| Study group | Role | What they receive |
|---|---|---|
| Association | Experimental | 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo Receives: Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association |
| Isolated ingredients | Active comparator | 0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations Receives: Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Infection and 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218737
- Sponsor's protocol ID
- AG9890X-001
- Status last verified
- Oct 2010
- First submitted
- 8 Oct 2010
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery
- ClinicalTrials.gov ID
- NCT01218737
- Acronym / sponsor ID
- AG9890X-001
- Conditions
- Ocular Infection and Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 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.
The purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Association | Experimental | Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops plus placebo |
| Isolated ingredients | Active comparator | Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate0.3% gatifloxacin and 1.0% prednisolone acetate isolated eye drops formulations |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient is indicated to have an ocular refractive surgery performed (myopia, astigmatism, hypermetropy) by the Lasik method.
- Patient presents a normal eye fundus.
- Patient has intraocular pressure (IOP) ≤ 20 mmHg.
Key exclusion criteria (6 listed)
- Surgery and/or previous ocular pathology (presence of scar/change in the cornea, glaucoma, retinopathies, etc.).
- Patient has diabetes or is immunodepressed.
- Any systemic infection during the study.
- Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal, caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
- Have used any systemic or topical antibiotics for ocular infection in the previous 14 days.
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 |
|---|---|---|
| 0.3% gatifloxacin and 1.0% prednisolone acetate associationAlso: ZypredEach patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15. | Drug | Association |
| isolated 0.3% gatifloxacin and 1.0% prednisolone acetateAlso: Zymar, Pred FortEach patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations. This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15. | Drug | Isolated ingredients |
Primary outcome
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
Time frame: Day 15
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 21 Mar 2018.
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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.
Medical Director study director
Allergan
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 0.3% gatifloxacin and 1.0% prednisolone acetate association and isolated 0.3% gatifloxacin and 1.0% prednisolone acetate in people with Ocular Infection and Inflammation, run by Federal University of São Paulo 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 6 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 21 Mar 2018. 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?
Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery. (time frame: Day 15). 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 21 Mar 2018.