Glaucoma
Conditions
Brief summary
A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration
Interventions
DRUGtimolol/dorzolamide combination
Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma * Patients with primary open-angle glaucoma based on gonioscopy * Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect. * Subjects with \< 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)
Exclusion criteria
* Patients with another type of glaucoma but primary open-angle glaucoma * Patients treated with other glaucoma medications within 6 weeks prior to study participation * Patients with a history of chronic ocular inflammation or recurrent ocular inflammation * Patients using contact lenses * Patients who are allergic to timolol or dorzolamide * Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications: * Reactive airway diseases * Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock * Severe renal impairment * Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study * Patients with a history of a corneal disease * Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. | Baseline and 12 weeks | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. | Baseline and 12 weeks | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. |
| Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP | Baseline and 12 weeks | The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline IOP | Baseline | Baseline IOP was measured at \ 9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant. |
Participant flow
Pre-assignment details
44 participants were actually screened. Among them, 7 participants failed in screening (2 participants withdrew and 5 did not meet eligibility criteria). Therefore 37 participants were considered to have enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Timolol/Dorzolamide Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Timolol/Dorzolamide |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 10.92 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol/Dorzolamide | Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP. | -3.73 mmHg | Standard Deviation 2.28 |
p-value: <0.0001paired t-test
Secondary
Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol/Dorzolamide | Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP | -3.78 mmHg | Standard Deviation 2.4 |
p-value: <0.0001paired t-test
Secondary
Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.
The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol/Dorzolamide | Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP. | -3.22 mmHg | Standard Deviation 2.14 |
p-value: <0.0001paired t-test
Other Pre-specified
Baseline IOP
Baseline IOP was measured at \ 9 AM of first day of treatment period. IOP was measured in both eyes and the eye with the higher IOP was used for the participant.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Timolol/Dorzolamide | Baseline IOP | 15.60 mmHg | Standard Deviation 2.46 |