Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
OAG, OHT
Brief summary
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension
Interventions
DRUGTravoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months
DRUGTravoprost 0.004% (BAK-preserved) Eye Drops, Solution
One drop once daily in the evening for 3 months
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, either gender and any race. * Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). * Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy. * All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits): ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential not meeting conditions set in the protocol. * Severe central visual field loss. * Angle Shaffer grade \< 2. * Cup/disc ratio \> 0.8 (horizontal or vertical measurement). * Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal). * Intraocular surgery or trauma within last 6 months. * Any abnormality preventing reliable applanation tonometry. * History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study. * Allergy/hypersensitivity to study medications. * Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit. * Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP. * Use of any additional topical or systemic ocular hypotensive medication during the study. * Therapy with another investigational agent within 30 days prior to the Screening visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure at 9:00 am | 3 months (measured at 9:00 am) | For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis |
| Mean Intraocular Pressure at 11:00 am | 3 months (measured at 11:00 am) | For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis |
| Mean Intraocular Pressure at 4:00 pm | 3 months (measured at 4:00 pm) | For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis |
Participant flow
Recruitment details
Patients were recruited from 30 study centers: 8 in the US, 6 in Mexico, 2 in Brazil, 4 in India, 2 in Australia, 2 in New Zealand, 2 in Latvia, and a single site in each: Taiwan, France, Belgium, and Italy.
Participants by arm
| Arm | Count |
|---|---|
| TRAVATAN APS One drop once daily in the evening for 3 months | 185 |
| TRAVATAN One drop once daily in the evening for 3 months | 186 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Inadequate Control of IOP | 1 | 1 |
| Overall Study | Noncompliance | 1 | 0 |
| Overall Study | Patient Moved | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | TRAVATAN APS | TRAVATAN | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 91 Participants | 77 Participants | 168 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 109 Participants | 203 Participants |
| Sex: Female, Male Female | 112 Participants | 115 Participants | 227 Participants |
| Sex: Female, Male Male | 73 Participants | 71 Participants | 144 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 185 | 35 / 186 |
| serious Total, serious adverse events | 1 / 185 | 2 / 186 |
Outcome results
Primary
Mean Intraocular Pressure at 11:00 am
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Time frame: 3 months (measured at 11:00 am)
Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TRAVATAN APS | Mean Intraocular Pressure at 11:00 am | 17.4 mmHg | Standard Error 0.25 |
| TRAVATAN | Mean Intraocular Pressure at 11:00 am | 17.5 mmHg | Standard Error 0.25 |
Comparison: A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.95% CI: [-0.8, 0.6]
Primary
Mean Intraocular Pressure at 4:00 pm
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Time frame: 3 months (measured at 4:00 pm)
Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TRAVATAN APS | Mean Intraocular Pressure at 4:00 pm | 16.9 mmHg | Standard Error 0.25 |
| TRAVATAN | Mean Intraocular Pressure at 4:00 pm | 17.1 mmHg | Standard Error 0.25 |
Comparison: A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.95% CI: [-0.9, 0.5]
Primary
Mean Intraocular Pressure at 9:00 am
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Time frame: 3 months (measured at 9:00 am)
Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TRAVATAN APS | Mean Intraocular Pressure at 9:00 am | 17.9 mmHg | Standard Error 0.25 |
| TRAVATAN | Mean Intraocular Pressure at 9:00 am | 18.1 mmHg | Standard Error 0.25 |
Comparison: A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.95% CI: [-0.9, 0.5]