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The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN | Active Comparator | TRAVATAN 0.004% once daily |
|
| Travoprost Vehicle | Placebo Comparator | Travoprost Vehicle |
|
| Travoprost Group A | Experimental | Travoprost Group A |
|
| Travoprost Group B | Experimental | Travoprost Group B |
|
| Travoprost Group C | Experimental | Travoprost Group C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% | Drug | 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 | Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| IOP Change From Baseline at 8 PM on Day 5 | Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment | 5 Days |
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Inclusion Criteria:
either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension
meets the following IOP entry criteria:
satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN | TRAVATAN 0.004% once daily |
| FG001 | Travoprost Vehicle | Travoprost Vehicle |
| FG002 | Travoprost Group A | Travoprost Group A |
| FG003 | Travoprost Group B | Travoprost Group B |
| FG004 | Travoprost Group C | Travoprost Group C |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRAVATAN | TRAVATAN 0.004% once daily |
| BG001 | Travoprost Vehicle | Travoprost Vehicle |
| 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) Change From Baseline at 8 AM on Day 5 | Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment | Posted | Mean | 95% Confidence Interval | mm Hg | 5 days |
|
1 month
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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 | TRAVATAN 0.004% once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pruritus | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Lt.d | 888.451.3937 | 817.568.67 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| 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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| Travoprost Vehicle | Drug | 1 drop in each eye 8 times daily for 5 days |
|
| Travoprost (Groups A, B and C) | Drug | 1 drop in each eye 8 times daily for 5 days |
|
| BG002 |
| Travoprost Group A |
Travoprost Group A |
| BG003 | Travoprost Group B | Travoprost Group B |
| BG004 | Travoprost Group C | Travoprost Group C |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG004 | Travoprost Group C |
|
|
| Secondary | IOP Change From Baseline at 8 PM on Day 5 | Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment | Posted | Mean | 95% Confidence Interval | mm Hg | 5 Days |
|
|
|
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | Travoprost Vehicle | Travoprost Vehicle | 0 | 14 | 2 | 14 |
| EG002 | Travoprost Group A | Travoprost Group A | 0 | 14 | 5 | 14 |
| EG003 | Travoprost Group B | Travoprost Group B | 0 | 13 | 8 | 13 |
| EG004 | Travoprost Group C | Travoprost Group C | 0 | 12 | 6 | 12 |
| Ocular Hyperaemia | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Eye Irritation | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Foreign Body Sensation | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Corneal Staining | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
| Headache | Eye disorders | MedDRA (version 13.0 | Non-systematic Assessment |
|
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| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |