Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
Interventions
DRUG0.1% brimonidine tartrate ophthalmic solution
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
DRUG0.01% bimatoprost ophthalmic solution
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
DRUG0.2% hypromellose lubricant eye drops
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
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 glaucoma in at least 1 eye * Visual acuity of 20/100 or better in both eyes
Exclusion criteria
* Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s) * Intraocular or glaucoma surgery in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | Baseline, Week 12 | IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ALPHAGAN® P and LUMIGAN® 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. | 70 |
| LUMIGAN® Alone 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks. | 67 |
| Total | 137 |
Baseline characteristics
| Characteristic | ALPHAGAN® P and LUMIGAN® | LUMIGAN® Alone | Total |
|---|---|---|---|
| Age Continuous | 65.7 Years STANDARD_DEVIATION 11.87 | 61.1 Years STANDARD_DEVIATION 13.91 | 63.4 Years STANDARD_DEVIATION 13.06 |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 64 Participants |
| Sex: Female, Male Male | 39 Participants | 34 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 70 | 0 / 67 |
| serious Total, serious adverse events | 1 / 70 | 2 / 67 |
Outcome results
Primary
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Time frame: Baseline, Week 12
Population: Per protocol population included all qualified participants who completed three months of treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALPHAGAN® P and LUMIGAN® | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | Baseline | 22.3 mm Hg | Standard Deviation 2.22 |
| ALPHAGAN® P and LUMIGAN® | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | Change from Baseline at Week 12 | -4.7 mm Hg | Standard Deviation 2.55 |
| LUMIGAN® Alone | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | Baseline | 22.2 mm Hg | Standard Deviation 2.44 |
| LUMIGAN® Alone | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) | Change from Baseline at Week 12 | -4.0 mm Hg | Standard Deviation 3.23 |