Glaucoma, Ocular Hypertension
Conditions
Brief summary
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.
Interventions
DRUGfixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.
DRUGbimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
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
* Diagnosed with glaucoma or ocular hypertension. * Visual Acuity 20/100 or better in both eyes
Exclusion criteria
* Any active ocular disease * History of any intraocular surgery or glaucoma laser surgery within 3 months * Contraindication to pupil dilation * Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Week 12 | Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combigan® + Lumigan® COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) | 59 |
| Lumigan® LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes | 62 |
| Total | 121 |
Baseline characteristics
| Characteristic | Combigan® + Lumigan® | Lumigan® | Total |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 10.52 | 62.6 years STANDARD_DEVIATION 13.19 | 63.3 years STANDARD_DEVIATION 11.93 |
| Sex: Female, Male Female | 28 Participants | 36 Participants | 64 Participants |
| Sex: Female, Male Male | 31 Participants | 26 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 59 | 1 / 62 |
| serious Total, serious adverse events | 0 / 59 | 0 / 62 |
Outcome results
Primary
Mean Diurnal Intraocular Pressure (IOP) at Week 12
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
Time frame: Week 12
Population: Intent-to-Treat (ITT) included all subjects who were randomized to study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combigan® + Lumigan® | Mean Diurnal Intraocular Pressure (IOP) at Week 12 | 15.4 Millimeters of mercury (mm Hg) | Standard Deviation 2.34 |
| Lumigan® | Mean Diurnal Intraocular Pressure (IOP) at Week 12 | 19.2 Millimeters of mercury (mm Hg) | Standard Deviation 3.42 |