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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002078-30 | EudraCT Number |
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The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRAVATAN | Experimental | Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months |
|
| LUMIGAN | Active Comparator | Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% ophthalmic solution | Drug | Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in IOP at Week 6 and Month 3 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Week 6, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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All enrolled subjects were randomized. This reporting group includes all randomized subjects (104). Note: 1 subject randomized to Travatan and 3 subjects randomized to Lumigan did not receive treatment.
Subjects were recruited from 2 study centers located in Slovenia.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRAVATAN | One drop to the study eye(s) once a day in the evening for 6 months |
| FG001 | LUMIGAN | One drop to the study eye(s) once a day in the evening, for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | TRAVATAN | One drop to the study eye(s) once a day in the evening for 6 months |
| BG001 | LUMIGAN | One drop to the study eye(s) once a day in the evening for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Intraocular Pressure (IOP) at Month 6 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 0), Month 6 |
|
Adverse events (AEs) were collected for the duration of the study (Sep 2012 - Jun 2014). This analysis population includes all subjects who received at least 1 dose of either study treatment.
An AE was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as both volunteered and elicited comments from the study 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 | One drop to the study eye(s) once a day in the evening for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboendarterectomy | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Lead, Medical Affairs, Glaucoma | Alcon Research, Ltd | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| 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 |
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| Bimatoprost 0.01% ophthalmic solution | Drug | Ophthalmic solution containing benzalkonium chloride (BAK) |
|
|
| Percentage of Subjects Who Reached Target IOP at Each Visit | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Week 6, Month 3, Month 6 |
| Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Week 6, Month 3, Month 6 |
| Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 |
| Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 |
| Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health. | Baseline (Day 0), Month 3, Month 6 |
| Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | Baseline (Day 0), Month 3, Month 6 |
| Withdrawal by Subject |
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| Noncompliance |
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| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| LUMIGAN |
One drop to the study eye(s) once a day in the evening for 6 months |
|
|
| Secondary | Mean Change From Baseline in IOP at Week 6 and Month 3 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 0), Week 6, Month 3 |
|
|
|
| Secondary | Percentage of Subjects Who Reached Target IOP at Each Visit | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Number | percentage of participants | Week 6, Month 3, Month 6 |
|
|
|
| Secondary | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point. | Posted | Number | participants | Baseline (Day 0), Week 6, Month 3, Month 6 |
|
|
|
| Secondary | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point. | Posted | Number | participants | Baseline (Day 0), Month 3, Month 6 |
|
|
|
| Secondary | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point. | Posted | Number | participants | Baseline (Day 0), Month 3, Month 6 |
|
|
|
| Secondary | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health. | This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Month 3, Month 6 |
|
|
|
| Secondary | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. | This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Month 3, Month 6 |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | LUMIGAN | One drop to the study eye(s) once a day in the evening for 6 months | 1 | 49 | 0 | 49 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| 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 |
| Month 6, n=46,43 |
|
| Baseline, Grade 2 |
|
| -1 Grade Change from Baseline at Week 6 |
|
| 0 Grade Change from Baseline at Week 6 |
|
| +1 Grade Change from Baseline at Week 6 |
|
| +2 Grade Change from Baseline at Week 6 |
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| -1 Grade Change from Baseline at Month 3 |
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| 0 Grade Change from Baseline at Month 3 |
|
| +1 Grade Change from Baseline at Month 3 |
|
| +2 Grade Change from Baseline at Month 3 |
|
| -1 Grade Change from Baseline at Month 6 |
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| 0 Grade Change from Baseline at Month 6 |
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| +1 Grade Change from Baseline at Month 6 |
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| +2 Grade Change from Baseline at Month 6 |
|
| Baseline, Grade 2 |
|
| -1 Grade Change from Baseline at Month 3 |
|
| 0 Grade Change from Baseline at Month 3 |
|
| +1 Grade Change from Baseline at Month 3 |
|
| -1 Grade Change from Baseline at Month 6 |
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| 0 Grade Change from Baseline at Month 6 |
|
| +1 Grade Change from Baseline at Month 6 |
|
| +2 Grade Change from Baseline at Month 6 |
|
| Baseline, Grade 2 |
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| Month 3, -1 Grade Change from Baseline |
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| Month 3, 0 Grade Change from Baseline |
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| Month 3, +1 Grade Change from Baseline |
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| Month 3, +2 Grade Change from Baseline |
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| Month 6, -1 Grade Change from Baseline |
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| Month 6, 0 Grade Change from Baseline |
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| Month 6, +1 Grade Change from Baseline |
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| Month 6, +2 Grade Change from Baseline |
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| Change from Baseline at Month 6, n=44,42 |
|
| Change from Baseline at Month 6, n=46,43 |
|