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The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. Patients will be randomized to receive either brand name or generic travoprost during the first visit. At the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. Patients will then receive the other formulation of travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brand name travoprost | Experimental | Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks. |
|
| Generic travoprost | Experimental | Patients will be randomized to either start in this arm for the first 3 weeks before the crossover to the other arm for the second 3 weeks or they will start in the other arm for the first 3 weeks before the crossover to this arm for the second 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brand name travoprost | Drug | Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | After 3 weeks of either the brand name or generic travoprost |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort and Intolerance to the Drops Questionnaire | Patients will be asked about:
| After 3 weeks of either the brand name or generic travoprost |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Carbonneau, MD, FRCS(C) | Université de Sherbrooke, Hôtel Dieu de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel-Dieu de Sherbrooke (CHUS) | Sherbrooke | Quebec | J1G 2E8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brand Name Travoprost First, Then Generic | Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
| FG001 | Generic Travoprost First, Then Brand Name | Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brand Name Travoprost First, Then Generic | Patients will be randomized to start with brand name travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to generic Travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
| 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 | Intraocular Pressure | There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms. | Posted | Mean | Standard Deviation | mm Hg | After 3 weeks of either the brand name or generic travoprost |
|
Three weeks for each intervention.
Safety Population included all participants who received at least one dose of intervention.
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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 | Brand Name Travoprost | Participants received Brand Name Travoprost one drop once daily for 3 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marjorie Carbonneau | University of Sherbrooke | 819-346-1110 | 22180 | Marjorie.Carbonneau@USherbrooke.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2016 | Jun 26, 2018 | Prot_SAP_000.pdf |
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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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|
|
| Generic travoprost | Drug | Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
|
|
| BG001 | Generic Travoprost First, Then Brand Name | Patients will be randomized to start with generic travoprost. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. A switch will be made to brand name travoprost. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline intraocular pressure | Median | Inter-Quartile Range | mm Hg |
|
| Mean deviation on visual field testing | Mean deviation on visual field testing gives an overall value of the total amount of visual field loss. The mean deviation value becomes more negative as the overall field worsens. | Median | Inter-Quartile Range | decibels |
|
| Number of Treatment Naive Participants | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Comfort and Intolerance to the Drops Questionnaire | Patients will be asked about:
| There were 70 patients that were analyzed overall and 70 patients in each arm. This is because this was a cross-over study therefore each patient was part of both arms. | Posted | Count of Participants | Participants | After 3 weeks of either the brand name or generic travoprost |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 1 |
| 76 |
| EG001 | Generic Travoprost | Participants received Generic Travoprost one drop once daily for 3 weeks. | 0 | 76 | 0 | 76 | 0 | 76 |
| Transient blurry vision | Eye disorders | 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 |
| Absent |
|
| Did you feel a burning sensation when administerin |
|
| Did your vision get blurry when administering the |
|
| Did your eyes get red when administering the drops |
|
| Are your eyes dry? |
|
| Do you get tearing or secretions in your eyes? |
|
| When you feel pain in your eyes when administering |
|
| Do your eyes itch when administering the drops? |
|
| Do you get a rash on the skin around your eyes? |
|