Ocular Hypertension, Open-Angle Glaucoma, Pigment Dispersion Glaucoma
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma, Intraocular pressure
Brief summary
The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).
Interventions
DRUGTravoprost 0.004%+Timolol 0.5% ophthalmic solution
Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)
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, open-angle or pigment dispersion glaucoma in at least one eye. * Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit. * IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period. * IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). * Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study. * Able to follow instructions and willing and able to attend all study visits. * Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye. * Sign informed consent. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator. * Corneal dystrophies in either eye. * Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * History of severe allergic rhinitis. * A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. * Participation in any other investigational study within 30 days prior to the Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline | Week 12 | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline | Week 12 | The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health. |
| Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline | Week 12 | Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis. |
| Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline | Week 4, Week 12 | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. |
| Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline | Week 4 | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. |
Participant flow
Recruitment details
Participants were recruited from 10 study centers in France and 3 study centers in Germany.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| DUOTRAV® Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Could Not Attend Visit | 1 |
| Overall Study | Withdrawal of Consent | 1 |
Baseline characteristics
| Characteristic | DUOTRAV® |
|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Time frame: Week 12
Population: All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUOTRAV® | Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline | Change from baseline at Week 12 | -3.8 millimeters mercury (mmHg) | Standard Deviation 1.9 |
| DUOTRAV® | Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline | Baseline (Day 1) | 20.0 millimeters mercury (mmHg) | Standard Deviation 1 |
Secondary
Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Time frame: Week 4
Population: All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUOTRAV® | Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline | Baseline (Day 1) | 20.1 millimeters mercury (mmHg) | Standard Deviation 1.1 |
| DUOTRAV® | Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline | Change from Baseline at Week 4 | -3.8 millimeters mercury (mmHg) | Standard Deviation 2.1 |
Secondary
Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline
Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.
Time frame: Week 12
Population: ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DUOTRAV® | Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline | -0.1 units on a scale | Standard Deviation 0.7 |
Secondary
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline
The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.
Time frame: Week 12
Population: ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUOTRAV® | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline | Baseline (Day 1) | 14.9 Units on a scale | Standard Deviation 10.9 |
| DUOTRAV® | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline | Change from Baseline at Week 12 | -3.6 Units on a scale | Standard Deviation 6.5 |
Secondary
Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Time frame: Week 4, Week 12
Population: ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUOTRAV® | Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline | Week 4 | 78.6 percentage of participants |
| DUOTRAV® | Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline | Week 12 | 85.5 percentage of participants |