search
Back to results

Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 0.03%
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Human Aqueous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All subjects must: Be willing and able to provide written Informed Consent. Be able and willing to follow instructions and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. 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.

Sites / Locations

  • University Hospital
  • Veterans Affairs Medical Center
  • Wishard Memorial Hospital
  • IU Eye at Carmel

Outcomes

Primary Outcome Measures

Bimatoprost free acid in human aqueous

Secondary Outcome Measures

Full Information

First Posted
July 20, 2006
Last Updated
October 16, 2007
Sponsor
Indiana University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00355446
Brief Title
Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.
Official Title
Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Human Aqueous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03%
Primary Outcome Measure Information:
Title
Bimatoprost free acid in human aqueous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All subjects must: Be willing and able to provide written Informed Consent. Be able and willing to follow instructions and likely to complete the entire course of the study. Be male or female of any race at least 18 years of age. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis B Cantor, MD
Organizational Affiliation
IUPUI/Clarian
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Eye at Carmel
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11545629
Citation
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.
Results Reference
background
PubMed Identifier
9698288
Citation
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.
Results Reference
background
PubMed Identifier
8022849
Citation
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.
Results Reference
background

Learn more about this trial

Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.

We'll reach out to this number within 24 hrs