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This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESTASIS® | Experimental | 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Drug | Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye | Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Month 6 |
| Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Month 6 |
| Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye | Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Month 6 |
| Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye | Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye | TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Jai Parekh | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates, Inc | Andover | Massachusetts | 01810 | United States | ||
| Total Eye Care, PA |
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| ID | Title | Description |
|---|---|---|
| FG000 | RESTASIS® | 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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51 participants were initially enrolled in the study, 1 participant discontinued before dosing and is not included in the Intent-to-treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | RESTASIS® | 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. |
| 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 |
| 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 | Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye | Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
|
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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 | RESTASIS® | 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary thyroid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| Baseline, Month 6 |
| Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Month 6 |
| Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye | Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | Baseline, Month 6 |
| Change From Baseline in Font Size | The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. | Baseline, Month 6 |
| Change From Baseline in Words Read Incorrectly | The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement. | Baseline, Month 6 |
| Change From Baseline in Time to Read Passage | The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage). | Baseline, Month 6 |
| Change From Baseline in Reading Rate | Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute). | Baseline, Month 6 |
| Baseline, Month 6 |
| Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye | A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection. | Baseline, Month 6 |
| Change From Baseline in Interblink Interval (IBI) in the Worst Eye | A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement. | Baseline, Month 6 |
| Change From Baseline in OSDI© Total Score | The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement. | Baseline, Month 6 |
| Change From Baseline in Driving at Night on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in Working With a Computer or Bank Machine on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in Watching Television (TV) on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in Blurred Vision on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in Poor Vision on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in Reading on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Baseline, Month 6 |
| Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye | Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement. | Baseline, Month 6 |
| Memphis |
| Tennessee |
| 38119 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Primary | Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye | Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Primary | Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye | Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Primary | Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Primary | Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye | Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement). | ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Primary | Change From Baseline in Font Size | The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. | ITT population was defined as all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | points | Baseline, Month 6 |
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| Primary | Change From Baseline in Words Read Incorrectly | The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement. | ITT population was defined as all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | incorrect words | Baseline, Month 6 |
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| Primary | Change From Baseline in Time to Read Passage | The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage). | ITT population was defined as all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | seconds | Baseline, Month 6 |
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| Primary | Change From Baseline in Reading Rate | Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute). | ITT population was defined as all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | correct words/minute | Baseline, Month 6 |
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| Secondary | Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye | TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening. | ITT population included all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | seconds | Baseline, Month 6 |
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| Secondary | Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye | A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection. | Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | percent of area | Baseline, Month 6 |
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| Secondary | Change From Baseline in Interblink Interval (IBI) in the Worst Eye | A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement. | ITT population included all enrolled participants who received at least 1 dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | seconds | Baseline, Month 6 |
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| Secondary | Change From Baseline in OSDI© Total Score | The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement. | ITT population included all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Driving at Night on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Working With a Computer or Bank Machine on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Watching Television (TV) on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Blurred Vision on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | ITT population included all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Poor Vision on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | ITT population included all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in Reading on the OSDI© | The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening. | ITT population included all enrolled participants who received at least one dose of study drug. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| Secondary | Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye | Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement. | Participant from the ITT population, all enrolled participants who received at least one dose of study drug, with data available for analysis. "n" in the category is the number of participants with data available at the given time-point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| 3 |
| 50 |
| 6 |
| 50 |
| Peripheral vascular disease | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D000602 |
| Amino Acids, Peptides, and Proteins |
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