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The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN, then LUMIGAN | Other | Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks |
|
| LUMIGAN, then TRAVATAN | Other | Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% ophthalmic solution | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Mean Intraocular Pressure (IOP) | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP at Each After Office Hour Evaluation Timepoint | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. | Week 6: 4 pm, 6 pm, 8 pm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doug Hubatsch, MS | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25432143 | Derived | DuBiner HB, Hubatsch DA. Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial. BMC Ophthalmol. 2014 Nov 28;14:151. doi: 10.1186/1471-2415-14-151. |
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This reporting group includes all enrolled subjects. A washout-period based on prior medication preceded Period 1 dispense.
Subjects were recruited from 2 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN, Then LUMIGAN | Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, First 6 Weeks |
|
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| Bimatoprost 0.01% ophthalmic solution | Drug |
|
|
| LUMIGAN, Then TRAVATAN |
Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2, Second 6 Weeks |
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This reporting group includes all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each |
| 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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| Region of Enrollment | Number | participants |
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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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean IOP at Each After Office Hour Evaluation Timepoint | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. | Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria. | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | Week 6: 4 pm, 6 pm, 8 pm |
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| Primary | Overall Mean Intraocular Pressure (IOP) | IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis. | Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria. | Posted | Mean | Standard Deviation | millimeters mercury (mmHg) | Week 6 |
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Adverse events were collected for the duration of the study.
Adverse events were obtained as solicited comments from the study subjects and as observations by the Study Investigator as outlined in the study protocol. This reporting group includes all enrolled subjects.
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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 | Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks | 0 | 84 | 0 | 84 | ||
| EG001 | LUMIGAN | Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks | 0 | 84 | 0 | 84 |
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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 | |
|---|---|---|---|---|
| Doug Hubatsch, Global Brand Leader, Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| D000069580 | Bimatoprost |
| 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 |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 8 pm (24 hours post dose) |
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