Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.
NCT ID: NCT00355446
Last Updated: 2007-10-17
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
48 participants
INTERVENTIONAL
2001-07-31
2004-10-31
Brief Summary
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* Bimatoprost levels in human aqueous peak approximately three hours post dosing
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
DOUBLE
Interventions
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Bimatoprost 0.03%
Eligibility Criteria
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Inclusion Criteria
1. Be willing and able to provide written Informed Consent.
2. Be able and willing to follow instructions and likely to complete the entire course of the study.
3. Be male or female of any race at least 18 years of age.
4. Have visually significant cataract for which they have elected to undergo cataract surgery..
Exclusion Criteria
1\. Have any contraindication to use of a prostaglandin analog or prostamide derivative.
3\. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.
4\. Have laser or any other intraocular surgery within the past three months. 5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. Patients may not have a history of ever having used a prostaglandin analog topically.
6\. Have known allergy or sensitivity to the study medications or their components 7. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.
8\. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
9\. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
10\. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
18 Years
ALL
No
Sponsors
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Indiana University School of Medicine
OTHER
Principal Investigators
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Louis B Cantor, MD
Role: PRINCIPAL_INVESTIGATOR
IUPUI/Clarian
Locations
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University Hospital
Indianapolis, Indiana, United States
Veterans Affairs Medical Center
Indianapolis, Indiana, United States
Wishard Memorial Hospital
Indianapolis, Indiana, United States
IU Eye at Carmel
Indianapolis, Indiana, United States
Countries
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References
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Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. doi: 10.1001/archopht.119.9.1254.
Sjoquist B, Basu S, Byding P, Bergh K, Stjernschantz J. The pharmacokinetics of a new antiglaucoma drug, latanoprost, in the rabbit. Drug Metab Dispos. 1998 Aug;26(8):745-54.
Basu S, Sjoquist B, Stjernschantz J, Resul B. Corneal permeability to and ocular metabolism of phenyl substituted prostaglandin esters in vitro. Prostaglandins Leukot Essent Fatty Acids. 1994 Apr;50(4):161-8. doi: 10.1016/0952-3278(94)90139-2.
Other Identifiers
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0106-24
Identifier Type: -
Identifier Source: org_study_id