NCT00355446

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2001

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
Last Updated

October 17, 2007

Status Verified

October 1, 2007

First QC Date

July 20, 2006

Last Update Submit

October 16, 2007

Conditions

Cataract

Keywords

CataractHuman Aqueous

Outcome Measures

Primary Outcomes (1)

  • Bimatoprost free acid in human aqueous

Interventions

Bimatoprost 0.03%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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..

You may not qualify if:

  • No subject may:
  • \. Have any contraindication to use of a prostaglandin analog or prostamide derivative.
  • \. 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.
  • \. 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.
  • \. 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.
  • \. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
  • \. 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).
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Veterans Affairs Medical Center

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Eye at Carmel

Indianapolis, Indiana, 46290, United States

Location

Related Publications (3)

  • 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.

    PMID: 11545629BACKGROUND

  • 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.

    PMID: 9698288BACKGROUND

  • 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.

    PMID: 8022849BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Louis B Cantor, MD

    IUPUI/Clarian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 24, 2006

Study Start

July 1, 2001

Study Completion

October 1, 2004

Last Updated

October 17, 2007

Record last verified: 2007-10

Locations

US(4)