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To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost 0.004% | Experimental | Travoprost 0.004% |
|
| Timolol 0.5% | Active Comparator | Timolol 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% Ophthalmic Solution (Travatan) | Drug | Travoprost at 9 AM + Placebo & 9 PM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | At Week 12 - At the 9 AM time point for the patient's worse eye. |
| Week 12 - Mean IOP At 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | At the 4 PM time point for the patient's worse eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP Change From Baseline at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Baseline to Week 12 - at 9 AM |
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Inclusion Criteria:
≥18 years;
IOP=16-30mmHg
OH or OAG with visual filed abnormality:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
Eligibility patients were washed out for up to 4 weeks before randomization
111 patients were enrolled in this study at 4 hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost 0.004% | Travoprost at 9 AM + Placebo & 9 PM |
| FG001 | Timolol 0.5% | Timolol in each eye, twice daily at 9 AM & 9 PM |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost 0.004% | Travoprost at 9 AM + Placebo & 9 PM |
| BG001 | Timolol 0.5% | Timolol in each eye, twice daily at 9 AM & 9 PM |
| 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 (IOP) at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | At Week 12 - At the 9 AM time point for the patient's worse eye. |
|
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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 | Travoprost 0.004% | Travoprost at 9 AM + Placebo & 9 PM |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Timolol 0.5% Ophthalmic Solution (Timoptic) | Drug | Timolol in each eye, twice daily at 9 AM & 9 PM |
|
| Mean IOP Change at 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Baseline to Week 12 - at 4 PM |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Mean IOP Change From Baseline at 9 AM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 12 - at 9 AM |
|
|
|
| Primary | Week 12 - Mean IOP At 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Posted | Mean | Standard Deviation | mmHg | At the 4 PM time point for the patient's worse eye. |
|
|
|
| Secondary | Mean IOP Change at 4 PM | Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged. | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 12 - at 4 PM |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Timolol 0.5% | Timolol in each eye, twice daily at 9 AM & 9 PM | 0 | 57 | 0 | 57 |
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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 |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |