Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
79 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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)
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
19 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Eung Kweon Kim, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital, Yousei University College of Medicine
Locations
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Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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SMA-08-22
Identifier Type: -
Identifier Source: org_study_id