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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024244-15 | EudraCT Number |
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The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.
At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZARGA/COSOPT | Other | 1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods. |
|
| COSOPT/AZARGA | Other | 1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred Treatment | The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage. | At the end of both periods, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Discomfort | Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort). | Day 7 of each period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Severine Durier, Pharm.D | Alcon Global Medical Affairs, Europe | Study Director |
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This reporting group includes all enrolled participants as treated.
Participants were recruited from 11 study centers located in Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZARGA/COSOPT | 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. |
| FG001 | COSOPT/AZARGA | 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 7 Days |
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| |||||||||||||||||||||
| Period 2, Second 7 Days |
|
This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, per planned treatment sequence (ITT full analysis population).
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| ID | Title | Description |
|---|---|---|
| BG000 | AZARGA/COSOPT | 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. |
| BG001 | COSOPT/AZARGA |
| 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 | Preferred Treatment | The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage. | This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated. | Posted | Number | Percentage of participants | At the end of both periods, Day 15 |
|
Adverse events were collected for the duration of the study (September 2011 to October 2012). An adverse event was defined as any untoward medical condition in a subject administered a study treatment regardless of causal relationship.
This reporting group includes all participants who received at least one dose of study medication. At each visit the Investigator inquired about adverse events by asking the standard question, "Have you had any health problems since your last study visit?"
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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 | AZARGA | 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hubatsch, Global Brand Leader, Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D013999 | Timolol |
| C571752 | Azarga |
| C062765 | dorzolamide |
| D009883 | Ophthalmic Solutions |
| C479140 | dorzolamide-timolol combination |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution |
| Drug |
|
|
| NOT COMPLETED |
|
|
1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2 |
|
|
| Secondary | Ocular Discomfort | Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort). | This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Day 7 of each period |
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | COSOPT | 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2 | 0 | 112 | 0 | 112 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| 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 |