Effect of Age on Latanoprost 0.005% in Patients With Glaucoma
NCT00224289
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Effect of Age on Latanoprost 0.005% in Patients With Glaucoma | |||
| Official Title ICMJE | Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma | |||
| 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. | |||
| 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Glaucoma | |||
| Intervention ICMJE | Drug: Latanoprost 0.005%
Latanoprost 0.005% ophthalmic solution QHS 8 weeks Other Name: Xalatan | |||
| Study Arms ICMJE | 1
All participants will be taking Latanoprost; This study compares efficacy within age groups. Intervention: Drug: Latanoprost 0.005% | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 17 | |||
| Original Enrollment ICMJE | 40 | |||
| Actual Study Completion Date ICMJE | April 2009 | |||
| Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00224289 | |||
| Other Study ID Numbers ICMJE | 27390 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Yale University | |||
| Study Sponsor ICMJE | Yale University | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Yale University | |||
| Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||