Glaucoma
Conditions
Keywords
Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP
Brief summary
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.
Interventions
DRUGTravoprost 0.004%/timolol maleate 0.5% fixed combination
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma; * Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye); * On a stable medication regimen for IOP reduction one week prior to the screening visit; * Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye; * Sign informed consent; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®; * Any abnormality that would preclude the reliable performance of applanation tonometry in either eye; * Infection in either eye; * Conventional or laser intraocular surgery in either eye 3 months prior to screening visit; * Risk for visual field or visual acuity worsening, in the opinion of the investigator; * Women of childbearing potential; * Pregnant or lactating women; * Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant. * Participation in another clinical study within 30 days before the screening visit; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) | Baseline, up to 6 weeks | As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and enrolled from 4 study centers located in Brazil.
Pre-assignment details
Of the 50 enrolled, 1 participant did not meet inclusion/exclusion criteria and was exited from the study prior to receiving study product. This reporting group includes all participants who received study product.
Participants by arm
| Arm | Count |
|---|---|
| DuoTrav Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | DuoTrav |
|---|---|
| Age Continuous | 63.3 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Brazil | 49 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 1 / 49 |
Outcome results
Primary
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Time frame: Baseline, up to 6 weeks
Population: Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuoTrav | Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) | -5.0 millimeters mercury (mmHg) | Standard Deviation 3.6 |