Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

NCT00224289

Last updated date
Study Location
Yale Eye Center
New Haven, Connecticut, 06510, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Age on Latanoprost 0.005% in Patients With Glaucoma
Official Title  ICMJE Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Drug: Latanoprost 0.005%
Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Other Name: Xalatan
Study Arms  ICMJE 1
All participants will be taking Latanoprost; This study compares efficacy within age groups.
Intervention: Drug: Latanoprost 0.005%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2012)
17
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
40
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00224289
Other Study ID Numbers  ICMJE 27390
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Bruce Shields, MDYale University
PRS Account Yale University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP