Glaucoma, Ocular Hypertension
Conditions
Brief summary
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
Interventions
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
Travoprost 0.004% administered to both eyes once daily for 12 weeks.
DRUGtimolol 0.5%
Timolol 0.5% administered to both eyes once daily for 12 weeks.
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ocular hypertension or glaucoma that requires treatment with medication * Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
Exclusion criteria
* History of LASIK, LASEK, RK, and/or PRK in the study eye(s) * History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months * Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 8 AM, 12 PM, and 4 PM | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost 0.01% and Hypromellose 0.3% Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. | 49 |
| Travoprost 0.004% and Timolol 0.5% Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Subject Withdrew Consent | 1 | 0 |
Baseline characteristics
| Characteristic | Bimatoprost 0.01% and Hypromellose 0.3% | Travoprost 0.004% and Timolol 0.5% | Total |
|---|---|---|---|
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 11.73 | 65.5 Years STANDARD_DEVIATION 9.98 | 64.5 Years STANDARD_DEVIATION 10.86 |
| Sex: Female, Male Female | 26 Participants | 20 Participants | 46 Participants |
| Sex: Female, Male Male | 23 Participants | 31 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Time frame: Week 12 at 8 AM, 12 PM, and 4 PM
Population: Intent-to-Treat: all subjects who were randomized to study medication with data at the noted time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost 0.01% and Hypromellose 0.3% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 8 AM (N=46, 50) | 16.7 Millimeters of Mercury (mmHg) | Standard Deviation 0.5 |
| Bimatoprost 0.01% and Hypromellose 0.3% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 12 PM (N=46, 50) | 16.2 Millimeters of Mercury (mmHg) | Standard Deviation 0.43 |
| Bimatoprost 0.01% and Hypromellose 0.3% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 4 PM (N=47, 50) | 16.0 Millimeters of Mercury (mmHg) | Standard Deviation 0.46 |
| Travoprost 0.004% and Timolol 0.5% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 8 AM (N=46, 50) | 15.4 Millimeters of Mercury (mmHg) | Standard Deviation 0.48 |
| Travoprost 0.004% and Timolol 0.5% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 12 PM (N=46, 50) | 15.6 Millimeters of Mercury (mmHg) | Standard Deviation 0.54 |
| Travoprost 0.004% and Timolol 0.5% | Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | Week 12 at 4 PM (N=47, 50) | 15.4 Millimeters of Mercury (mmHg) | Standard Deviation 0.6 |