Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224289
• Other study ID #: 27390
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: November 9, 2012
• Start date: March 2005
• Est. completion date: April 2009

Study information

• Verified date: November 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Yale Eye Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Treatment IOP (Intraocular Pressure)	Subjects applied topical latanoprost at bedtime for 8 weeks	At baseline (before treatment)	No
Primary	Post-Treatment IOP (Intraocular Pressure)	Subjects applied topical latanoprost at bedtime for 8 weeks	8 Weeks	No