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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000161-13 | EudraCT Number |
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The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN® BAK-free | Experimental | Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% | Drug | Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Severine Durier, Pharm.D | Alcon Research | Study Director |
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Of the 202 subjects enrolled, 1 subject was exited as a screen failure and 2 subjects withdrew consent prior to dosing. This reporting group includes all subjects who instilled at least one dose of the test article (199).
Subjects were recruited from 15 investigative sites located in Europe: Belgium (2); Spain (6); Italy (4); Sweden (3).
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN® BAK-free | Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This reporting group includes all subjects who instilled at least one dose of the test article
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| ID | Title | Description |
|---|---|---|
| BG000 | TRAVATAN® BAK-free | Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. | The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, "n" is the number of participants with non-missing values at the specific time point. | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | Baseline, Week 12 |
|
Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months).
This reporting group includes all subjects who instilled at least one dose of the test article.
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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® BAK-free | Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal hemmorhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch, Global Brand Leader, Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Inability to Follow Instructions |
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| Other |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. | The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit. | Posted | Number | Percentage of participants | Week 12 |
|
|
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| 4 |
| 199 |
| 0 |
| 199 |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.