Cataract ExtractionPhase 4NCT00840580
Effect on Wound Healing of Vigamox Versus Cravit
A Phase 4 study testing Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Levofloxacin 0.5% ophthalmic solution (Cravit) in people with Cataract Extraction, run by Alcon Research at 1 site in South Korea.
Trial summary
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Levofloxacin 0.5% ophthalmic solution (Cravit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any race and either sex, and over the age of 18, who are scheduled for removal of a cataract and implantation of a posterior chamber intraocular lens using clear corneal incisions or near-clear corneal incisions.
- Intraocular pressure (IOP) readings, treated or untreated, less than or equal to 20 mmHg prior to surgery. Glaucoma patients are eligible if an ocular hypotensive agent (only one) controls their IOP.
- Other than cataracts, have normal healthy eyes as determined by the ophthalmic examination and case history.
- Subconjunctival injections right after cataract surgery are allowed.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any cataract wound that is stitched or any gross abrasion of the epithelium after removal of a cataract and implantation of a posterior chamber intraocular lens.
- Fluorescein staining of the cornea at baseline.
- History or evidence of ocular or systemic disease, which would preclude participation in this study. Examples could include autoimmune disease affecting the cornea as well as any corneal dystrophies.
- History of ocular inflammatory disease, ocular herpes infection, iritis, uveitis, or Sjögren's syndrome.
- Known or suspected allergy or hypersensitivity to levofloxacin or any related medicines, such as cinoxacin (Cinobac), ciprofloxacin (Cipro or Ciloxan), norfloxacin (Chibroxin or Noroxin), ofloxacin (Floxin), or nalidixic acid (NegGram), preservatives, dyes, or any components of the study medication.
- Treatment for an ocular infection within 30 days prior to study entry.
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- Use of topical or systemic steroids within 7 days prior to study entry.
- Use of topical anti inflammatory drugs within 7 days prior to study entry.
- Pregnancy, nursing/lactation, or inadequate birth control methods. Oral contraceptives are allowed.
- Patients with uncontrolled diabetes and/or diabetic retinopathy.
- No ointment is used after cataract surgery.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Study Comparing Effect on Wound Healing of Vigamox (Moxifloxacin 0.5% Ophthalmic Solution) and Cravit (Levofloxacin 0.5% Ophthalmic Solution) Administered Post-Surgically in Patients Undergoing Cataract Extraction
The purpose of this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.
- Conditions
- Cataract Extraction
- Being tested
- Moxifloxacin 0.5% ophthalmic solution (Vigamox), Levofloxacin 0.5% ophthalmic solution (Cravit)
- Keywords
- Cataract, Cornea, Vigamox, Cravit
- Medical subject headings
- Cataract, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin 0.5% ophthalmic solution (Vigamox)Drug
Also called Vigamox
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
Levofloxacin 0.5% ophthalmic solution (Cravit)Drug
Also called Cravit
One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery.
| Study group | Role | What they receive |
|---|---|---|
| Vigamox | Experimental | One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. Receives: Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox) |
| Cravit | Active comparator | One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. Receives: Drug: Levofloxacin 0.5% ophthalmic solution (Cravit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with epithelial defect
The eye was imaged. An epithelial defect was defined as a non-continuous epithelium. The eye was considered healed when the defect was no longer visible.
Measured: Day 1, Day 2, Day 3, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eung Kweon Kim, MD/PhD, Principal investigator, Severance Hospital, Yousei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840580
- Sponsor's protocol ID
- SMA-08-22
- Status last verified
- Jul 2012
- First submitted
- 9 Feb 2009
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Han KE, Chung WS, Kim TI, Kim S, Kim T, Kim EK. Epithelial wound healing after cataract surgery comparing two different topical fluoroquinolones. Yonsei Med J. 2014 Jan;55(1):197-202. doi: 10.3349/ymj.2014.55.1.197.
PubMed 24339307
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study Comparing Effect on Wound Healing of Vigamox (Moxifloxacin 0.5% Ophthalmic Solution) and Cravit (Levofloxacin 0.5% Ophthalmic Solution) Administered Post-Surgically in Patients Undergoing Cataract Extraction
- ClinicalTrials.gov ID
- NCT00840580
- Acronym / sponsor ID
- SMA-08-22
- Conditions
- Cataract Extraction
- Keywords
- Cataract, Cornea, Vigamox, Cravit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- First posted
- 10 Feb 2009 (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 this study was to compare the effects of Vigamox and Cravit on corneal wound healing after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigamox | Experimental | Drug: Moxifloxacin 0.5% ophthalmic solution (Vigamox)One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. |
| Cravit | Active comparator | Drug: Levofloxacin 0.5% ophthalmic solution (Cravit)One drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of any race and either sex, and over the age of 18, who are scheduled for removal of a cataract and implantation of a posterior chamber intraocular lens using clear corneal incisions or near-clear corneal incisions.
- Intraocular pressure (IOP) readings, treated or untreated, less than or equal to 20 mmHg prior to surgery. Glaucoma patients are eligible if an ocular hypotensive agent (only one) controls their IOP.
- Other than cataracts, have normal healthy eyes as determined by the ophthalmic examination and case history.
- Subconjunctival injections right after cataract surgery are allowed.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (12 listed)
- Any cataract wound that is stitched or any gross abrasion of the epithelium after removal of a cataract and implantation of a posterior chamber intraocular lens.
- Fluorescein staining of the cornea at baseline.
- History or evidence of ocular or systemic disease, which would preclude participation in this study. Examples could include autoimmune disease affecting the cornea as well as any corneal dystrophies.
- History of ocular inflammatory disease, ocular herpes infection, iritis, uveitis, or Sjögren's syndrome.
- Known or suspected allergy or hypersensitivity to levofloxacin or any related medicines, such as cinoxacin (Cinobac), ciprofloxacin (Cipro or Ciloxan), norfloxacin (Chibroxin or Noroxin), ofloxacin (Floxin), or nalidixic acid (NegGram), preservatives, dyes, or any components of the study medication.
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% ophthalmic solution (Vigamox)Also: VigamoxOne drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. | Drug | Vigamox |
| Levofloxacin 0.5% ophthalmic solution (Cravit)Also: CravitOne drop 4 times a day in study eye for one week prior to surgery, followed by one drop 4 times a day for two weeks beginning Day 1 post surgery. | Drug | Cravit |
Primary outcome
Percentage of patients with epithelial defect
Time frame: Day 1, Day 2, Day 3, Day 10
The eye was imaged. An epithelial defect was defined as a non-continuous epithelium. The eye was considered healed when the defect was no longer visible.
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 23 Jul 2012.
- Derived from this study: PubMed 24339307Han KE, Chung WS, Kim TI, Kim S, Kim T, Kim EK. Epithelial wound healing after cataract surgery comparing two different topical fluoroquinolones. Yonsei Med J. 2014 Jan;55(1):197-202. doi: 10.3349/ymj.2014.55.1.197.
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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.
Eung Kweon Kim, MD/PhD principal investigator
Severance Hospital, Yousei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Levofloxacin 0.5% ophthalmic solution (Cravit) in people with Cataract Extraction, run by Alcon Research at 1 site in South Korea.
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 12 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 23 Jul 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 patients with epithelial defect (time frame: Day 1, Day 2, Day 3, Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840580, which also lists 1 linked publication.
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 23 Jul 2012.