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This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemihydrate/maleate/maleate gel | Active Comparator | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% |
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| maleate/maleate gel/hemihydrate | Active Comparator | Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% |
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| maleate gel/hemihydrate/maleate | Active Comparator | Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% |
|
| hemihydrate/maleate gel/maleate | Active Comparator | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% |
|
| maleate/hemihydrate/maleate gel |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate in Sorbate | Drug | 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stinging on Instillation | Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable. | following 3 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Hyperemia | Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia. | following 3 days of treatment |
| Tear Film Break-up Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William C. Stewart, MD | PRN Pharmacuetical Research Network, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bourbonnais | Illinois | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemihydrate/Maleate/Maleate Gel | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% |
| FG001 | Maleate/Maleate Gel/Hemihydrate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| Active Comparator |
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% |
|
| maleate gel, maleate, hemihydrate | Active Comparator | Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% |
|
| Timolol hemihydrate | Drug | 0.5% |
|
| Timolol maleate gel forming solution | Drug | 0.5% |
|
| following 3 days of treatment |
| Corneal Staining Grade | Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining. | following 3 days of treatment |
| Corneal Staining Count | Assessed by the investigator using a slit lamp, counting the number of spots. | following 3 days of treatment |
| Intraoclular Pressure | following 3 days of treatment |
| Basic Schirmer's | Schirmer's measures basic tear function. The higher the number, the less dry the eye. | following 3 days of treatment |
| Conjunctival Staining - Nasal Grade | Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining. | following 3 days of treatment |
| Conjunctival Staining - Nasal Count | Assessed by investigator using slit lamp and counting number of spots. | following 3 days of treatment |
| Conjunctival Staining - Temporal Grade | Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining. | following 3 days of treatment |
| Conjunctival Staining - Temporal Count | Assessed by investigator using a slit lamp and counting number of spots. | following 3 days of treatment |
| Visual Acuity | The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision. | following 3 days of treatment |
| Charlotte |
| North Carolina |
| United States |
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
| FG002 | Maleate Gel/Hemihydrate/Maleate | Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5% |
| FG003 | Hemihydrate/Maleate Gel/Maleate | Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5% |
| FG004 | Maleate/Hemihydrate/Maleate Gel | Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5% |
| FG005 | Maleate Gel/Maleate/Hemihydrate | Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5% |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention |
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| Third Invervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall |
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stinging on Instillation | Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable. | Posted | Mean | Standard Deviation | Units on a scale | following 3 days of treatment |
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| Secondary | Conjunctival Hyperemia | Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia. | Posted | Mean | Standard Deviation | Units on a scale | following 3 days of treatment |
|
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| Secondary | Tear Film Break-up Time | Posted | Mean | Standard Deviation | Seconds | following 3 days of treatment |
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| Secondary | Corneal Staining Grade | Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining. | Posted | Mean | Standard Deviation | Units on a scale | following 3 days of treatment |
|
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| Secondary | Corneal Staining Count | Assessed by the investigator using a slit lamp, counting the number of spots. | Posted | Mean | Standard Deviation | Number of spots | following 3 days of treatment |
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| Secondary | Intraoclular Pressure | Posted | Mean | Standard Deviation | mm of mercury | following 3 days of treatment |
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| Secondary | Basic Schirmer's | Schirmer's measures basic tear function. The higher the number, the less dry the eye. | Posted | Mean | Standard Deviation | mm of moisture | following 3 days of treatment |
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| Secondary | Conjunctival Staining - Nasal Grade | Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining. | Posted | Mean | Standard Deviation | Units on a scale | following 3 days of treatment |
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| Secondary | Conjunctival Staining - Nasal Count | Assessed by investigator using slit lamp and counting number of spots. | Posted | Mean | Standard Deviation | number of spots | following 3 days of treatment |
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| Secondary | Conjunctival Staining - Temporal Grade | Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining. | Posted | Mean | Standard Deviation | Units on a scale | following 3 days of treatment |
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| Secondary | Conjunctival Staining - Temporal Count | Assessed by investigator using a slit lamp and counting number of spots. | Posted | Mean | Standard Deviation | number of spots | following 3 days of treatment |
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| Secondary | Visual Acuity | The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision. | Posted | Mean | Standard Deviation | number of letters | following 3 days of treatment |
|
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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 | Timolol Hemihydrate 0.5% | 0 | 30 | 2 | 30 | |||
| EG001 | Timolol Maleate 0.5% | 0 | 30 | 2 | 30 | |||
| EG002 | Timolol Maleate Gel Forming Solution 0.5% | 0 | 30 | 0 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tearing | Eye disorders | Non-systematic Assessment |
| ||
| Blurred Vision | Eye disorders | Non-systematic Assessment |
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Prior to submission for publication or presentation, the PI will provide the Sponsor with at least 60 days for review of a manuscript. If requested in writing, the PI will withhold publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Shedden MD | Vistakon | 904-443-1557 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| ID | Term |
|---|---|
| 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 |
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