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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006027-31 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN APS | Experimental | One drop once daily in the evening for 3 months |
|
| TRAVATAN | Active Comparator | One drop once daily in the evening for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution | Drug | One drop once daily in the evening for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months (measured at 9:00 am) |
| 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 | 3 months (measured at 11:00 am) |
| 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 | 3 months (measured at 4:00 pm) |
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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:
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN APS | One drop once daily in the evening for 3 months |
| FG001 | TRAVATAN | One drop once daily in the evening for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRAVATAN APS | One drop once daily in the evening for 3 months |
| BG001 | TRAVATAN | One drop once daily in the evening for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | mmHg | 3 months (measured at 9:00 am) |
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRAVATAN APS | One drop once daily in the evening for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal mass | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Alcon Clinical | Alcon Research, Ltd. | 888.451.3937 or 817.568.6725 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Travoprost 0.004% (BAK-preserved) Eye Drops, Solution | Drug | One drop once daily in the evening for 3 months |
|
| Protocol Violation |
|
| Noncompliance |
|
| Inadequate Control of IOP |
|
| Patient Moved |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One drop once daily in the evening for 3 months
| OG001 | TRAVATAN | One drop once daily in the evening for 3 months |
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | mmHg | 3 months (measured at 11:00 am) |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | mmHg | 3 months (measured at 4:00 pm) |
|
|
|
|
| 1 |
| 185 |
| 32 |
| 185 |
| EG001 | TRAVATAN | One drop once daily in the evening for 3 months | 2 | 186 | 35 | 186 |
| Chest pain | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
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| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
The non-inferiority margin was 1.5 mmHg. |
The non-inferiority margin was 1.5 mmHg. |