Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclosporine 0.05% ophthalmic emulsion | Experimental | Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine 0.05% ophthalmic emulsion | Drug | Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye | Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Baseline, Month 6 |
| Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Baseline, Month 6 |
| Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye | Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Baseline, Month 6 |
| Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in OSDI | The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover | Massachusetts | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27257373 | Background | Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cyclosporine 0.05% Ophthalmic Emulsion | Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine 0.05% Ophthalmic Emulsion | Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed 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, 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 Total Corneal Staining Score With Fluorescein in the Worse Eye | Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclosporine 0.05% Ophthalmic Emulsion | Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| carboxymethylcellulose-based lubricant eye drops | Drug | Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months. |
|
|
| Baseline, Month 6 |
| Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) | The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading 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 Driving at Night on the OSDI | The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading 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 is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading 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 TV on the OSDI | The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading 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 Rate | Reading speed is assessed as the number of words read correctly in 2 minutes. | Baseline, Month 6 |
| Change From Baseline in Words Read Incorrectly | The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement. | Baseline, Month 6 |
| Change From Baseline in Font Size | The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline, Month 6 |
| Baseline, Month 6 |
| Change From Baseline in Ocular Discomfort on a 4-point Scale | Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Baseline, Month 6 |
| Change From Baseline in Tear Film Break-up Time 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. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening. | Baseline, Month 6 |
| Change From Baseline in the Interblink Interval in the Worse Eye | The interblink interval measures the time (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 Conjunctival Redness in the Worse Eye | Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Baseline, Month 6 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye | Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). 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). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening). | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) | The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | 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 is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | 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 is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Watching TV on the OSDI | The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Reading Rate | Reading speed is assessed as the number of words read correctly in 2 minutes. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Words/Minute | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Words Read Incorrectly | The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Words | Baseline, Month 6 |
|
|
|
| Primary | Change From Baseline in Font Size | The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Size | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in OSDI | The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. 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. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in Ocular Discomfort on a 4-point Scale | Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in Tear Film Break-up Time 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. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Seconds | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in the Interblink Interval in the Worse Eye | The interblink interval measures the time (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. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Seconds | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in Conjunctival Redness in the Worse Eye | Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Intent-to-Treat: all enrolled patients who received at least one dose of the study drug | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 6 |
|
|
|
| 2 |
| 40 |
| 12 |
| 40 |
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Instillation Site Burn | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Instillation Site Pain | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
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 |