Glaucoma
Conditions
Keywords
Latanoprost, Glaucoma, Intraocular pressure
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.
Interventions
Latanoprost 0.005% ophthalmic solution QHS 8 weeks
Sponsors
Pfizer
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Treatment IOP (Intraocular Pressure) | At baseline (before treatment) | Subjects applied topical latanoprost at bedtime for 8 weeks |
| Post-Treatment IOP (Intraocular Pressure) | 8 Weeks | Subjects applied topical latanoprost at bedtime for 8 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Topical Latanoprost |
|---|---|
| Age Continuous | 61.6 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Post-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks
Time frame: 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Latanoprost | Post-Treatment IOP (Intraocular Pressure) | 18.3 mm Hg | Standard Deviation 5.36 |
Primary
Pre-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks
Time frame: At baseline (before treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Latanoprost | Pre-Treatment IOP (Intraocular Pressure) | 21.8 mm Hg | Standard Deviation 6.28 |