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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000011621 | Registry Identifier | UMIN |
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The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN Z | Experimental | Travoprost Ophthalmic Solution 0.004%, 1 drop instilled in each eye once daily at 9PM for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost Ophthalmic Solution 0.004% | Drug | benzalkonium chloride (BAC) free |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis. | Baseline (Day 0), Week 4, Week 8, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danyel Carr, MS | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Japan, Ltd. | Tokyo | Japan |
This reporting group includes all enrolled subjects (32).
Subjects were recruited from 5 study sites located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN Z | Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.
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| ID | Title | Description |
|---|---|---|
| BG000 | TRAVATAN Z | Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Baseline IOP | Mean | Standard Deviation | mmHg |
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| 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 From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis. | This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline (Day 0), Week 4, Week 8, Week 12 |
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Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). This analysis population includes all subjects enrolled in the study, minus any subject whose safety evaluation data is all missed (1 subject).
An AE was defined as any medically undesirable event that develops in a subject that received the study drug regardless of causal relationship with the study drug.
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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 Z | Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months. | 0 | 31 | 0 | 31 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Phase IV | Alcon Japan, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D057066 | Low Tension Glaucoma |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| 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 |
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| 5:00 PM |
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