Effect of Age on 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 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|
- 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
|Study Start Date:||March 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224289
|United States, Connecticut|
|Yale Eye Center|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Bruce Shields, MD||Yale University|