Eye Infection/Inflammation OtherPhase 3NCT01603030
Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation
A Phase 3 study testing moxifloxacin 0,5% + prednisolone 1% and moxifloxacin/prednisolone combination in people with Eye Infection/Inflammation Other, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.
Trial summary
This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Eye Infection/Inflammation Other
- What is being tested?
- moxifloxacin 0,5% + prednisolone 1% and moxifloxacin/prednisolone combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Sep 2012
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women of any race, between 18 and 50 years of age up to 8 degrees of myopia or hyperopia of up to 04 degrees or up to 3 degrees without astigmatism and other eye problems associated.
- Able to understand and provide informed consent,
- Willingness to complete all required study visits,
- Willingness to undergo surgery to correct grade (myopia, astigmatism, hyperopia) by LASIK in both eyes (at the same surgical or surgical procedures separated) or in only one eye.
- Examination of normal fundus by direct ophthalmoscopy or indirect;
- Measurements of intraocular pressure (IOP), treated or untreated, less than or equal to 20 mmHg. Individuals with glaucoma / ocular hypertension are eligible if their blood pressure is controlled by a single ocular hypotensive agent with the exception noted in criterion of exclusion. 16.
- Women who may become pregnant (those that are not surgically sterile or postmenopausal) may participate in the study if they meet all the following conditions: a)not breastfeeding; b)have a negative pregnancy test at screening prior to recruitment; c)agree to submit to a urine test for pregnancy at the time of its withdrawal from the study; d)not to conceive during the study period; e)are using birth control methods appropriate and agrees to continue to use birth control methods appropriate for the duration of the study (the methods of birth control are adequate: hormonal contraceptives - oral, implantable or injectable; mechanics - spermicide associated with a barrier method like a condom or diaphragm, IUD, or sterilization of the partner).
Who cannot join
- Glaucoma or intraocular hypertension not controlled;
- Use of nonsteroidal antiinflammatory drugs (NSAIDs) ocular topical or systemic drugs (NSAIDs) during the study and the 14 days prior to study entry, except for an allowed daily dose of aspirin low-dose (100 mg);
- Ocular anti-infective drug use during the study and within 30 days prior to study entry or any other eye medicines with the exception noted in criterion Insertion 6.
- Topical steroids, inhaled or systemic ocular during the study and the 14 days prior to study entry;
- Ocular trauma in the eye prior to operate (including intraocular surgery in the previous twelve months due to trauma or cataract in the past);
- History of chronic ocular inflammatory disease or recurrent (ie, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the eye to be operated;
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- Any intraocular inflammation (score of cells than Grade 0) to be present during the examination of slit lamp or ocular pain increased in the Grade 1 -2 Day in the study eye (eye operation);
- Proliferative diabetic retinopathy (eye operation) non-proliferative diabetic retinopathy, moderate to severe (eye operation);
- Uncontrolled diabetes mellitus;
- Patients with vision in one eye or vision not correctable to LogMAR 1.0 or better in each eye using the ETDRS framework;
- Participation in any other clinical study within 12 months prior to surgery, pregnant women, lactating or under conditions of breeding methods that are not using adequate birth control (as defined in the criteria for inclusion, above);
- Known or suspected allergy or hypersensitivity to moxifloxacin, steroids, topical anesthetics or any other component of the study medication;
- History or other evidence of severe illness, or other systemic conditions that may cause the patient, in the opinion of the Investigator, the study is inadequate;
- Patients with epithelial herpes simplex (dendritic keratitis), vaccinia, varicella, or other viral disease of the cornea or conjunctiva, tuberculosis of the eye, fungal diseases of ocular structures;
- Patients who use a topical ophthalmic prostaglandin, such as ,Travatan® (travoprost),Xalatan®(latanoprost),Lumigan®(bimatoprost)and Rescula®(unoprostone) should discontinue their use starting four days before surgery until their departure from study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
São Paulo, SP/Brazil, 4562-020
Rubens Belfort, investigator, 55115572-6443, prof.belfort@clinicabelfort.com.br
Luci Silva, coordinator, 55115572-6443, luci@oftalmo.epm.br
About this study
Official title: Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery
This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK surgery.
Read the detailed description
antibiotic/steroid combination compared to individuals components 15 days of treatment
- Conditions
- Eye Infection/Inflammation Other
- Being tested
- moxifloxacin 0,5% + prednisolone 1%, moxifloxacin/prednisolone combination
- Keywords
- Moxifloxacin, Prednisolone, LASIK
- Medical subject headings
- Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacin 0,5% + prednisolone 1%Drug
Also called moxifloxacin 0,5%, prednisolone 1%
1 gtt, 4x/day, 15 days
moxifloxacin/prednisolone combinationDrug
Also called moxifloxacin 0,5%; predfort
1 gtt, 4x/day, 15 days
| Study group | Role | What they receive |
|---|---|---|
| moxifloxacin/prednisolone combination | Experimental | 1 gtt, 4x/day, 15 days Receives: Drug: moxifloxacin/prednisolone combination |
| moxifloxacin 0,5% + Prednisolone 1% | Active comparator | 1 drop of each bottle, BID, 15 days Receives: Drug: moxifloxacin 0,5% + prednisolone 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 15 Evaluation of Anterior Chamber
The primary efficacy variable of this study is the percentage of patients with a score of zero postoperative inflammation (anterior chamber inflammation, ie, presence of cells in the anterior chamber (0-4) in the study on Day 15. The absence of bacterial infection on Day 15 ± 1 will be assumed to demonstrate that the antibacterial agents in the association of moxifloxacin / acetate Prednisolona1% and moxifloxacin + acetate Prednisolona1% Eye drops are equal in antimicrobial effectiveness, and that they acted in a prophylactic manner to prevent of bacterial infection.
Measured: 15 days
Secondary outcomes (1)
day 15 physician´s follow-up impression of inflammatory reaction score
the clinical evaluation will be based on the following variables: IOP, assessment of visual acuity, slit lamp examination (lids, conjunctiva, cornea), and examination of the fundus (retina / macula / choroid, vitreous and optic nerve).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Infection/Inflammation OtherStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristina Mucioli, Dra., Study chair, Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603030
- Sponsor's protocol ID
- ADAMOXPRE01/10
- Status last verified
- May 2012
- First submitted
- 22 Mar 2011
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery
- ClinicalTrials.gov ID
- NCT01603030
- Acronym / sponsor ID
- ADAMOXPRE01/10
- Conditions
- Eye Infection/Inflammation Other
- Keywords
- Moxifloxacin, Prednisolone, LASIK
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 22 May 2012 (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.
This is a Unicentric, double-blind, randomized, two-arm, parallel-group study to demonstrate the efficacy of moxifloxacin/prednisolone acetate fixed combination compared with individual administration of moxifloxacin + acetate Prednisolone Eye drops in Prevention of Post Operative Inflammation and Infection in LASIK surgery.
Detailed description
antibiotic/steroid combination compared to individuals components 15 days of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moxifloxacin/prednisolone combination | Experimental | Drug: moxifloxacin/prednisolone combination1 gtt, 4x/day, 15 days |
| moxifloxacin 0,5% + Prednisolone 1% | Active comparator | Drug: moxifloxacin 0,5% + prednisolone 1%1 drop of each bottle, BID, 15 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men or women of any race, between 18 and 50 years of age up to 8 degrees of myopia or hyperopia of up to 04 degrees or up to 3 degrees without astigmatism and other eye problems associated.
- Able to understand and provide informed consent,
- Willingness to complete all required study visits,
- Willingness to undergo surgery to correct grade (myopia, astigmatism, hyperopia) by LASIK in both eyes (at the same surgical or surgical procedures separated) or in only one eye.
- Examination of normal fundus by direct ophthalmoscopy or indirect;
Key exclusion criteria (15 listed)
- Glaucoma or intraocular hypertension not controlled;
- Use of nonsteroidal antiinflammatory drugs (NSAIDs) ocular topical or systemic drugs (NSAIDs) during the study and the 14 days prior to study entry, except for an allowed daily dose of aspirin low-dose (100 mg);
- Ocular anti-infective drug use during the study and within 30 days prior to study entry or any other eye medicines with the exception noted in criterion Insertion 6.
- Topical steroids, inhaled or systemic ocular during the study and the 14 days prior to study entry;
- Ocular trauma in the eye prior to operate (including intraocular surgery in the previous twelve months due to trauma or cataract in the past);
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 |
|---|---|---|
| moxifloxacin 0,5% + prednisolone 1%Also: moxifloxacin 0,5%, prednisolone 1%1 gtt, 4x/day, 15 days | Drug | moxifloxacin 0,5% + Prednisolone 1% |
| moxifloxacin/prednisolone combinationAlso: moxifloxacin 0,5%; predfort1 gtt, 4x/day, 15 days | Drug | moxifloxacin/prednisolone combination |
Primary outcome
Day 15 Evaluation of Anterior Chamber
Time frame: 15 days
The primary efficacy variable of this study is the percentage of patients with a score of zero postoperative inflammation (anterior chamber inflammation, ie, presence of cells in the anterior chamber (0-4) in the study on Day 15. The absence of bacterial infection on Day 15 ± 1 will be assumed to demonstrate that the antibacterial agents in the association of moxifloxacin / acetate Prednisolona1% and moxifloxacin + acetate Prednisolona1% Eye drops are equal in antimicrobial effectiveness, and that they acted in a prophylactic manner to prevent of bacterial infection.
1 secondary outcome
day 15 physician´s follow-up impression of inflammatory reaction score
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
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.
Cristina Mucioli, Dra. study chair
Universidade Federal de São Paulo - Hospital São Paulo - UNIFESP
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 moxifloxacin 0,5% + prednisolone 1% and moxifloxacin/prednisolone combination in people with Eye Infection/Inflammation Other, run by Adapt Produtos Oftalmológicos Ltda. 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens Belfort, investigator (5511 5572-6443, prof.belfort@clinicabelfort.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 15 Evaluation of Anterior Chamber (time frame: 15 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 22 May 2012.