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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.
Patients enrolled in this study completed a validated survey instrument (COMTOL) examining tolerability of topically applied ophthalmic medications that they are already taking in their regular course of care for glaucoma. The purpose of the study is to determine whether side effects and symptoms of the drugs already being taken cause problems with activities of daily living.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost | These patients take bimatoprost topically for glaucoma. | ||
| latanoprost group | These patients take latanoprost topically for glaucoma. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Medications as Measured by the COMTOL Validated Instrument | Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects. | at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study |
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Inclusion Criteria:
Exclusion Criteria:
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Patients taking either study medication for glaucoma.
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| Name | Affiliation | Role |
|---|---|---|
| John A. Hovanesian, MD | UCLA Jules Stein Eye Institute | Principal Investigator |
| Savak Teymoorian, MD | Harvard Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost | These patients take bimatoprost topically for glaucoma. |
| FG001 | Latanoprost Group | These patients take latanoprost topically for glaucoma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost | These patients take bimatoprost topically for glaucoma. |
| BG001 | Latanoprost Group | These patients take latanoprost topically for glaucoma. |
| 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 | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects. | Posted | Number | percentage of patients | at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study |
|
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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 | Bimatoprost | These patients take bimatoprost topically for glaucoma. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Hovanesian, MD | MDbackline, LLC | 949 951 9248 | jhovanesian@mdbackline.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Note patients will be recruited to fill out a questionnaire, describing their symptoms related to glaucoma use drops. In this study, we are examining only patients taking either bimatoprost or latanoprost, thus 2 cohorts. However, this is not an interventional study, and there will be only one study visit (enrollment and questionnaire at the same time) and no change in the patient's prescribed therapy.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
These patients take bimatoprost topically for glaucoma.
| OG001 | Latanoprost Group | These patients take latanoprost topically for glaucoma. |
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Latanoprost Group | These patients take latanoprost topically for glaucoma. | 0 | 110 | 0 | 110 |
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