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Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355446
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : October 17, 2007
Sponsor:
Information provided by:
Indiana University

Brief Summary:

The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a prostaglandin F-2-alpha analog in human eyes

  • Bimatoprost levels in human aqueous peak approximately three hours post dosing

Condition or disease Intervention/treatment Phase
Cataract Drug: Bimatoprost 0.03% Phase 4

Detailed Description:
The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous.
Study Start Date : July 2001
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Bimatoprost




Primary Outcome Measures :
  1. Bimatoprost free acid in human aqueous


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must:

    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:

  • No subject may:

    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355446


Locations
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United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202
Veterans Affairs Medical Center
Indianapolis, Indiana, United States, 46202
Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
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Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
Publications:
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ClinicalTrials.gov Identifier: NCT00355446    
Other Study ID Numbers: 0106-24
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007
Keywords provided by Indiana University:
Cataract
Human Aqueous
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents