Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost-to-tafluprost | Other | Travoprost first, with tafluprost second. Each product dosed for six weeks. |
|
| Tafluprost-to-travoprost | Other | Tafluprost first, with travoprost second. Each product dosed for six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% ophthalmic solution (TRAVATAN) | Drug | One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 8:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 8:00 AM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| Mean Intraocular Pressure (IOP) at 10:00 AM | Intraocular pressure was measured by Goldmann applanation tonometry. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients were recruited from four private practices located in Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost-to-tafluprost | Travoprost, then tafluprost |
| FG001 | Tafluprost-to-travoprost | Tafluprost, then travoprost |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, First 6 Weeks |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tafluprost 0.0015% ophthalmic solution | Drug | One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration |
|
| 6 weeks |
| Mean Intraocular Pressure (IOP) at 12:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| Mean Intraocular Pressure (IOP) at 2:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| Mean Intraocular Pressure (IOP) at 4:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| Mean Intraocular Pressure (IOP) at 6:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | 6 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2, Second 6 Weeks |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost-to-tafluprost | Travoprost, then tafluprost |
| BG001 | Tafluprost-to-travoprost | Tafluprost, then travoprost |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 (IOP) at 8:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 8:00 AM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 10:00 AM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 12:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 2:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 4:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Intraocular Pressure (IOP) at 6:00 PM | Intraocular pressure was measured by Goldmann applanation tonometry. | This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs. | Posted | Mean | Standard Deviation | mm Hg | 6 weeks |
|
|
Adverse events were collected for the duration of the study: 10-September-2009 to 2-March-2010.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Travoprost | One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically | 0 | 51 | 0 | 51 | ||
| EG001 | Tafluprost | One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically | 0 | 48 | 0 | 48 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Alcon Research, Ltd. | 1-800-862-5266 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| C485333 | tafluprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|