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Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Latanoprost 0.005%
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Latanoprost, Glaucoma, Intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: diagnosis of open angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes; IOP above their target pressure as determined by a glaucoma specialist; willingness to participate in the study. Exclusion Criteria: hypersensitivity to any of the components of the treatment medication; previous use of topical prostaglandins; documented ocular infection or intraocular inflammation within the past year; previous filtering surgery or complicated cataract surgery; active corneal disease; presence of cystoid macular edema; laser trabeculoplasty or any other ocular laser procedure within the past three months.

Sites / Locations

  • Yale Eye Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

All participants will be taking Latanoprost; This study compares efficacy within age groups.

Outcomes

Primary Outcome Measures

Pre-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks
Post-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
November 9, 2012
Sponsor
Yale University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00224289
Brief Title
Effect of Age on Latanoprost 0.005% in Patients With Glaucoma
Official Title
Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset. We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.
Detailed Description
Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996). However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off. To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance. Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Latanoprost, Glaucoma, Intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
All participants will be taking Latanoprost; This study compares efficacy within age groups.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Other Intervention Name(s)
Xalatan
Intervention Description
Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Primary Outcome Measure Information:
Title
Pre-Treatment IOP (Intraocular Pressure)
Description
Subjects applied topical latanoprost at bedtime for 8 weeks
Time Frame
At baseline (before treatment)
Title
Post-Treatment IOP (Intraocular Pressure)
Description
Subjects applied topical latanoprost at bedtime for 8 weeks
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: diagnosis of open angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes; IOP above their target pressure as determined by a glaucoma specialist; willingness to participate in the study. Exclusion Criteria: hypersensitivity to any of the components of the treatment medication; previous use of topical prostaglandins; documented ocular infection or intraocular inflammation within the past year; previous filtering surgery or complicated cataract surgery; active corneal disease; presence of cystoid macular edema; laser trabeculoplasty or any other ocular laser procedure within the past three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shields, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Eye Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

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