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OpenTrials
Completed

NCT Number: NCT00224289

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale Eye Center

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Latanoprost 0.005%

Drug

Latanoprost 0.005% ophthalmic solution QHS 8 weeks

Other names: Xalatan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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