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The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in patients with chronic angle-closure glaucoma (CACG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost 0.004% (Travatan) | Experimental | One drop in each eye, once daily at 9 AM |
|
| Pilocarpine 1% | Active Comparator | One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% (Travatan) | Drug | One drop in each eye, once daily at 9 AM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) | 4PM at Week 12 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Peripheral Anterior Synechiae (PAS) | Week 12 Visit |
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Inclusion Criteria:
Exclusion Criteria:
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Patients randomized at 1:1 ratio into two treatment groups
30 patients were enrolled in this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost 0.004% (Travatan) | Travoprost 0.004% Ophthalmic Solution |
| FG001 | Pilocarpine 1% | Pilocarpine 1% Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost 0.004% (Travatan) | Travoprost 0.004% Ophthalmic Solution |
| BG001 | Pilocarpine 1% | Pilocarpine 1% Ophthalmic Solution |
| 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) | Posted | Mean | Standard Deviation | millimeters mercury (mm Hg) | 4PM at Week 12 Visit |
|
|
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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% (Travatan) | Travoprost 0.004% Ophthalmic Solution |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Pilocarpine 1% | Drug | One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Patients With Peripheral Anterior Synechiae (PAS) | Posted | Number | Participants | Week 12 Visit |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Pilocarpine 1% | Pilocarpine 1% Ophthalmic Solution | 0 | 14 | 0 | 14 |
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| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |