Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.

Cataract Clinical Trial

Official title:

Bioavailabilty of Bimatoprost Ophthalmic Solution in Human Aqueous.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355446
• Other study ID #: 0106-24
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2006
• Last updated: October 16, 2007
• Start date: July 2001
• Est. completion date: October 2004

Study information

• Verified date: October 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Bimatoprost 0.03%

Locations

Country	Name	City	State
United States	IU Eye at Carmel	Indianapolis	Indiana
United States	University Hospital	Indianapolis	Indiana
United States	Veterans Affairs Medical Center	Indianapolis	Indiana
United States	Wishard Memorial Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

Basu S, Sjöquist 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. — View 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. — View Citation

Sjöquist 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bimatoprost free acid in human aqueous