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Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224289
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 10, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Latanoprost 0.005% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
Study Start Date : March 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
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 Name: Xalatan

Primary Outcome Measures :
  1. Pre-Treatment IOP (Intraocular Pressure) [ Time Frame: At baseline (before treatment) ]
    Subjects applied topical latanoprost at bedtime for 8 weeks

  2. Post-Treatment IOP (Intraocular Pressure) [ Time Frame: 8 Weeks ]
    Subjects applied topical latanoprost at bedtime for 8 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224289

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United States, Connecticut
Yale Eye Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
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Principal Investigator: Bruce Shields, MD Yale University

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Responsible Party: Yale University Identifier: NCT00224289     History of Changes
Other Study ID Numbers: 27390
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 10, 2012
Last Update Posted: December 10, 2012
Last Verified: November 2012

Keywords provided by Yale University:
Intraocular pressure

Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Antihypertensive Agents