Open-angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.
Interventions
timolol hemihydrate 0.5% solution
DRUGtimolol maleate
timolol maleate in sorbate
Sponsors
Vistakon Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* willing to comply with investigator's and protocol's instructions * patients signature on the informed consent document * open-angle glaucoma or ocular hypertension * currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye
Exclusion criteria
* inability to understand the trial procedures * inability to give informed consent * inability to understand, read, or write English * best corrected visual acuity of 20/200 or worse in each eye * current moderate to severe infectious or inflammatory condition of the eye or eyelids including * current moderate to severe dry eye syndrome * current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months * treated with 3 or more glaucoma medicines in both eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Burning/Stinging | Upon instillation | Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always. |
| Subject Reported Tearing | Upon instillation. | Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always. |
| Subject Reported Light Sensitivity | Upon instillation | Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always. |
| Subject Reported Blurred Vision | Upon instillation | Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Subject Population All subjects responding to survey | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | Total Subject Population |
|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Subject Reported Blurred Vision
Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.
Time frame: Upon instillation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol Hemihydrate | Subject Reported Blurred Vision | 0.7 Units on a Scale | Standard Deviation 1 |
| Timolol Maleate in Sorbate | Subject Reported Blurred Vision | 0.6 Units on a Scale | Standard Deviation 1 |
p-value: 0.69t-test, 2 sided
Primary
Subject Reported Burning/Stinging
Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.
Time frame: Upon instillation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol Hemihydrate | Subject Reported Burning/Stinging | 1.1 Units on a Scale | Standard Deviation 1.1 |
| Timolol Maleate in Sorbate | Subject Reported Burning/Stinging | 2.4 Units on a Scale | Standard Deviation 1.4 |
p-value: <0.001t-test, 2 sided
Primary
Subject Reported Light Sensitivity
Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.
Time frame: Upon instillation
Population: Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol Hemihydrate | Subject Reported Light Sensitivity | 0.5 Units on a Scale | Standard Deviation 0.7 |
| Timolol Maleate in Sorbate | Subject Reported Light Sensitivity | 0.4 Units on a Scale | Standard Deviation 0.9 |
p-value: 0.75t-test, 2 sided
Primary
Subject Reported Tearing
Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.
Time frame: Upon instillation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol Hemihydrate | Subject Reported Tearing | 0.9 Units on a Scale | Standard Deviation 1 |
| Timolol Maleate in Sorbate | Subject Reported Tearing | 1.6 Units on a Scale | Standard Deviation 1.6 |
p-value: 0.024t-test, 2 sided