Official Title: “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 Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Latanoprost 0.005%
  • Latanoprost 0.005% ophthalmic solution QHS 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • All participants will be taking Latanoprost; This study compares efficacy within age groups.

Primary Measures

• Pressure lowering effect
  • Time Frame: November 2008
    Safety Issue?: No

Secondary Measures

• Tolerance of medication
  • Time Frame: November 2008
    Safety Issue?: No
• Effect on Central Corneal Thickness
  • Time Frame: November 2008
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Bruce Shields, MD Principal Investigator Yale University  

Overall Contact: Ann Leone, COT 203-785-6150 ann.leone@yale.edu

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00224289

Study ID Number: 27390

ClinicalTrials.gov Identifier: NCT00224289

Health Authority: United States: Food and Drug Administration