Ocular Hypertension, Glaucoma
Conditions
Brief summary
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension
Interventions
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular hypertension or chronic glaucoma * Patient requires IOP-lowering therapy in both eyes
Exclusion criteria
* Uncontrolled medical conditions * Hypersensitivity to study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Baseline, Week 12 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Baseline, Week 18 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.03% Eye Drops Bimatoprost 0.03% eye drops | 270 |
| Latanoprost 0.005% Eye Drops Latanoprost 0.005% eye drops | 273 |
| Total | 543 |
Baseline characteristics
| Characteristic | Bimatoprost 0.03% Eye Drops | Latanoprost 0.005% Eye Drops | Total |
|---|---|---|---|
| Age, Customized < 45 years | 9 participants | 16 participants | 25 participants |
| Age, Customized > 65 years | 150 participants | 137 participants | 287 participants |
| Age, Customized Between 45 and 65 years | 111 participants | 120 participants | 231 participants |
| Sex: Female, Male Female | 147 Participants | 155 Participants | 302 Participants |
| Sex: Female, Male Male | 123 Participants | 118 Participants | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 269 | 89 / 586 |
| serious Total, serious adverse events | 4 / 269 | 11 / 586 |
Outcome results
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time frame: Baseline, Week 12
Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Week 12 | -5.64 millimeters of mercury (mmHg) | Standard Deviation 2.968 |
| Bimatoprost 0.03% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Baseline | 21.90 millimeters of mercury (mmHg) | Standard Deviation 3.656 |
| Latanoprost 0.005% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Week 12 | -4.89 millimeters of mercury (mmHg) | Standard Deviation 2.872 |
| Latanoprost 0.005% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Baseline | 22.16 millimeters of mercury (mmHg) | Standard Deviation 3.569 |
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time frame: Baseline, Week 18
Population: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.03% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Baseline | 21.90 millimeters of mercury (mmHg) | Standard Deviation 3.656 |
| Bimatoprost 0.03% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Week 18 | -5.77 millimeters of mercury (mmHg) | Standard Deviation 3.023 |
| Latanoprost 0.005% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Baseline | 22.16 millimeters of mercury (mmHg) | Standard Deviation 3.569 |
| Latanoprost 0.005% Eye Drops | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Week 18 | -5.09 millimeters of mercury (mmHg) | Standard Deviation 2.709 |