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The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travalert with travoprost/timolol fixed combination | Experimental | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
|
| Travalert with travoprost and timolol | Experimental | One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav) | Drug | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Francisco M. Honrubia | Independent | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zaragoza | Zaragoza | 50009 | Spain |
Baseline characteristics are presented for the per-protocol population.
Patients were recruited from 5 hospitals in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travalert With Travoprost/Timolol Fixed Combination | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
| FG001 | Travalert With Travoprost and Timolol | One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Travalert With Travoprost/Timolol Fixed Combination | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
| BG001 | Travalert With Travoprost and Timolol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Adherence | Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time. | Per protocol | Posted | Number | percentage of adherent patients | 6 months |
|
Adverse events were collected for the duration of the study: 2 years, 3 months.
The safety population includes all enrolled patients.
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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 | Travalert With Travoprost/Timolol Fixed Combination | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Severine Durier, PharmD | Alcon France | +33 1 47 10 48 43 |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D013999 | Timolol |
| C571754 | Duotrav |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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|
| Travoprost 0.004% eye drops | Drug | One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. |
|
| Timolol 0.05% eye drops | Drug | One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device. |
|
| Travalert Dosing Aid | Device | Approved device used with study medication to record time of instillation and quantify dosing |
|
One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 1 |
| 52 |
| 0 |
| 52 |
| EG001 | Travalert With Travoprost and Timolol | One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. | 1 | 50 | 0 | 50 |
| Brachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
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| D015438 | Health Behavior |
| D001519 | Behavior |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| 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 |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |