Effect of Age on Latanoprost 0.005% in Patients With Glaucoma

• ClinicalTrials.gov Identifier: NCT00224289
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: December 10, 2012
• Last Update Posted: December 10, 2012
• Sponsor: Yale University
• Collaborator: Pfizer
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Drug: Latanoprost 0.005%	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
• Study Start Date: March 2005
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Pre-Treatment IOP (Intraocular Pressure) [ Time Frame: At baseline (before treatment) ]
   Subjects applied topical latanoprost at bedtime for 8 weeks
2. Post-Treatment IOP (Intraocular Pressure) [ Time Frame: 8 Weeks ]
   Subjects applied topical latanoprost at bedtime for 8 weeks

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00224289
• Other Study ID Numbers: 27390
• First Posted: September 22, 2005
• Results First Posted: December 10, 2012
• Last Update Posted: December 10, 2012
• Last Verified: November 2012

Keywords provided by Yale University:

Latanoprost; Glaucoma; Intraocular pressure

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions