Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

November 9, 2012 updated by: Yale University

Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
All participants will be taking Latanoprost; This study compares efficacy within age groups.
Drug: Latanoprost 0.005%
Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Other Names:
  • Xalatan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Treatment IOP (Intraocular Pressure)
Time Frame: At baseline (before treatment)
Subjects applied topical latanoprost at bedtime for 8 weeks
At baseline (before treatment)
Post-Treatment IOP (Intraocular Pressure)
Time Frame: 8 Weeks
Subjects applied topical latanoprost at bedtime for 8 weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Bruce Shields, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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