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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | All participants will be taking Latanoprost; This study compares efficacy within age groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost 0.005% | Drug | Latanoprost 0.005% ophthalmic solution QHS 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Treatment IOP (Intraocular Pressure) | Subjects applied topical latanoprost at bedtime for 8 weeks | At baseline (before treatment) |
| Post-Treatment IOP (Intraocular Pressure) | Subjects applied topical latanoprost at bedtime for 8 weeks | 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Shields, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Eye Center | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Latanoprost | All participants will be taking Latanoprost; This study compares efficacy within age groups. Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Latanoprost | All participants will be taking Latanoprost; This study compares efficacy within age groups. Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre-Treatment IOP (Intraocular Pressure) | Subjects applied topical latanoprost at bedtime for 8 weeks | Posted | Mean | Standard Deviation | mm Hg | At baseline (before treatment) |
|
|
Adverse event information was collected for 8 weeks per subject. The subjects received the study medication for 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Latanoprost | All participants will be taking Latanoprost; This study compares efficacy within age groups. Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Red Eye w/ Foreign Body Sensation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Shields, MD | Principal Investigator | 203-785-6288 | bruce.shields@yale.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Post-Treatment IOP (Intraocular Pressure) | Subjects applied topical latanoprost at bedtime for 8 weeks | Posted | Mean | Standard Deviation | mm Hg | 8 Weeks |
|
|
|
| 0 |
| 17 |
| 3 |
| 17 |
| Eye Tearing | Eye disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |