Glaucoma
Conditions
Keywords
glaucoma, bimatoprost, latanoprost, tolerability
Brief summary
This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.
Detailed description
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.
Interventions
None listed
Sponsors
Allergan
MDbackline, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with glaucoma taking either bimatoprost or latanoprost
Exclusion criteria
* patients taking other medication or with other causes for ocular surface symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Medications as Measured by the COMTOL Validated Instrument | at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost These patients take bimatoprost topically for glaucoma. | 101 |
| Latanoprost Group These patients take latanoprost topically for glaucoma. | 110 |
| Total | 211 |
Baseline characteristics
| Characteristic | Bimatoprost | Latanoprost Group | Total |
|---|---|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 12 | 73.4 years STANDARD_DEVIATION 12.1 | 74.4 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 101 participants | 110 participants | 211 participants |
| Sex: Female, Male Female | 63 Participants | 56 Participants | 119 Participants |
| Sex: Female, Male Male | 38 Participants | 54 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 110 |
| serious Total, serious adverse events | 0 / 101 | 0 / 110 |
Outcome results
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.
Time frame: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bimatoprost | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Itching More than A Little | 23 percentage of patients |
| Bimatoprost | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Burning/Stinging More Than A Little | 26 percentage of patients |
| Bimatoprost | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Redness More Than A Little | 31 percentage of patients |
| Bimatoprost | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Dry Eyes More Than A Little | 47 percentage of patients |
| Latanoprost Group | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Dry Eyes More Than A Little | 54 percentage of patients |
| Latanoprost Group | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Itching More than A Little | 50 percentage of patients |
| Latanoprost Group | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Redness More Than A Little | 42 percentage of patients |
| Latanoprost Group | Tolerability of Medications as Measured by the COMTOL Validated Instrument | Bothered by Burning/Stinging More Than A Little | 29 percentage of patients |