Post Lasik Surgery InflammationNCT00330824
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery
A study testing antibiotic/steroid combination and moxifloxacin/dexamethasone in people with Post Lasik Surgery Inflammation, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Lasik Surgery Inflammation
- What is being tested?
- antibiotic/steroid combination and moxifloxacin/dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Dec 2006
- Phase
- Interventional
- 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
- patients having LASIK surgery;
- men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems
Who cannot join
- Uncontrolled glaucoma or intraocular hypertension;
- Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
- A history of chronic or recurrent ocular inflammatory disease;
- Uncontrolled diabetes mellitus and diabetic retinopathy ;
- Patients with sight in a single eye;
- Iris atrophy in the eye to be operated;
Show all 9Show fewer
- Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
- Known or suspected allergy or hypersensitivity to any component of study medication;
- A history or any other evidence of severe systemic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dept. of Ophthalmology - Rua Botucatu 824
São Paulo, São Paulo, 04023-062
About this study
Official title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK
Read the detailed description
antibiotic/steroid combination compared to individuals components 15 days of treatment
- Conditions
- Post Lasik Surgery Inflammation
- Being tested
- antibiotic/steroid combination, moxifloxacin/dexamethasone
- Keywords
- prevention of post inflammation in LASIK surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic/steroid combinationDrug
Also called moxifloxacin/dexamethasone
1gtt, 4x/d, 15 days
moxifloxacin/dexamethasoneDrug
Also called moxifloxacin / dexamethasone
1gtt, 4x/days, 15 days
| Study group | Role | What they receive |
|---|---|---|
| antibiotic steroid (single vial) | Experimental | efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery Receives: Drug: antibiotic/steroid combination |
| antibiotic / steroid (2 vials) | Active comparator | efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery Receives: Drug: moxifloxacin/dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
day 15 evaluation of anterior chamber
Measured: 15 days pos-op
Secondary outcomes (1)
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
Measured: 15 days pos-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Lasik Surgery 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rubens Belfort Jr, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330824
- Sponsor's protocol ID
- BRA-05-02
- Status last verified
- Aug 2009
- First submitted
- 26 May 2006
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery
- ClinicalTrials.gov ID
- NCT00330824
- Acronym / sponsor ID
- BRA-05-02
- Conditions
- Post Lasik Surgery Inflammation
- Keywords
- prevention of post inflammation in LASIK surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 29 May 2006 (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.
Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK
Detailed description
antibiotic/steroid combination compared to individuals components 15 days of treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic steroid (single vial) | Experimental | Drug: antibiotic/steroid combinationefficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery |
| antibiotic / steroid (2 vials) | Active comparator | Drug: moxifloxacin/dexamethasoneefficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients having LASIK surgery;
- men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems
Key exclusion criteria (9 listed)
- Uncontrolled glaucoma or intraocular hypertension;
- Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
- A history of chronic or recurrent ocular inflammatory disease;
- Uncontrolled diabetes mellitus and diabetic retinopathy ;
- Patients with sight in a single eye;
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 |
|---|---|---|
| antibiotic/steroid combinationAlso: moxifloxacin/dexamethasone1gtt, 4x/d, 15 days | Drug | antibiotic steroid (single vial) |
| moxifloxacin/dexamethasoneAlso: moxifloxacin / dexamethasone1gtt, 4x/days, 15 days | Drug | antibiotic / steroid (2 vials) |
Primary outcome
day 15 evaluation of anterior chamber
Time frame: 15 days pos-op
1 secondary outcome
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
Time frame: 15 days pos-op
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 Aug 2009.
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.
Rubens Belfort Jr, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic/steroid combination and moxifloxacin/dexamethasone in people with Post Lasik Surgery 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 2 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 Aug 2009. 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.
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?
day 15 evaluation of anterior chamber (time frame: 15 days pos-op). 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 Aug 2009.