Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00224289
First received: September 16, 2005
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Glaucoma
Drug: Latanoprost 0.005%
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pre-Treatment IOP (Intraocular Pressure) [ Time Frame: At baseline (before treatment) ] [ Designated as safety issue: No ]
    Subjects applied topical latanoprost at bedtime for 8 weeks

  • Post-Treatment IOP (Intraocular Pressure) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Subjects applied topical latanoprost at bedtime for 8 weeks


Enrollment: 17
Study Start Date: March 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Xalatan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224289

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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00224289     History of Changes
Other Study ID Numbers: 27390
Study First Received: September 16, 2005
Results First Received: November 9, 2012
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Latanoprost
Glaucoma
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014