Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
Open Angle Glaucoma, Ocular Hypertension, Intraocular Pressure
Brief summary
The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.
Interventions
DRUGBeta-blocker monotherapy
Per participant's current prescribed therapy
DRUGTravoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a clinical diagnosis of either open angle glaucoma or ocular hypertension. * Currently on beta-blocker monotherapy (for \>30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction. * Have a mean baseline lOP of \>18 mmHg and \<32 mmHg in at least one eye. * Must be able to understand and sign an Informed Consent form. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Use of medication excluded by the protocol. * Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol. * Ocular surgeries or procedures excluded by the protocol. * Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal). * Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator. * Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye | Week 4 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis. |
| Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | Baseline (Day 0), Week 4 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Participants were recruited from 14 investigational centers located in Latin America, Australia, Russia, and Korea.
Pre-assignment details
Of the 157 participants enrolled, 1 participant was exited as a screen failure. This reporting group includes all randomized participants (156).
Participants by arm
| Arm | Count |
|---|---|
| DuoTrav Travoprost/timolol for 8 weeks | 78 |
| Beta-blocker 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol | 73 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | DuoTrav | Beta-blocker | Total |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 12.76 | 63.8 years STANDARD_DEVIATION 13.29 | 63.3 years STANDARD_DEVIATION 12.98 |
| Sex: Female, Male Female | 54 Participants | 52 Participants | 106 Participants |
| Sex: Female, Male Male | 24 Participants | 21 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 81 | 9 / 75 |
| serious Total, serious adverse events | 0 / 81 | 0 / 75 |
Outcome results
Primary
Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
Time frame: Week 4
Population: Intent to treat with a measurement in the study eye at Week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| DuoTrav | Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye | 16.6129 mmHg |
| Beta-blocker | Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye | 21.2320 mmHg |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Intent to treat with a measurement in the study eye at Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuoTrav | Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | -5.840 mmHg | Standard Deviation 3.487 |
| Beta-blocker | Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | -1.069 mmHg | Standard Deviation 2.4969 |
Secondary
Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Week 4
Population: Intent to treat with a measurement in the study eye at Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuoTrav | Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | -25.365 Percent Change | Standard Deviation 14.2093 |
| Beta-blocker | Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | -4.716 Percent Change | Standard Deviation 11.4005 |