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This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-223575 Dose A | Experimental | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
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| AGN-223575 Dose B | Experimental | 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
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| AGN-223575 Dose C | Experimental | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
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| AGN-223575 Vehicle | Placebo Comparator | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-223575 ophthalmic solution | Drug | AGN-223575 ophthalmic solution once or twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale | Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement. | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale | OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Clinical Trials | Phoenix | Arizona | 85003 | United States | ||
| Specialty Eye Ctr. Med. Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | AGN-223575 Dose A | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| FG001 | AGN-223575 Dose B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| AGN-223575 vehicle ophthalmic solution | Drug | Vehicle to AGN22375 ophthalmic solution once or twice daily. |
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| Baseline, Day 14 |
| Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale | The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement. | Baseline, Day 14 |
| Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye | A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness). | Day 14 |
| Glendale |
| California |
| 91203 |
| United States |
| The Eye Research Foundation | Newport Beach | California | 92663 | United States |
| WCCT Global | Santa Ana | California | 92705 | United States |
| Eye Associates of Colorado Springs | Colorado Springs | Colorado | 80909 | United States |
| West Coast Eye Institute | Lecanto | Florida | 34491 | United States |
| Eye Care Centers Management, Inc. | Morrow | Georgia | 30260 | United States |
| Coastal Research Assoc. LLC | Roswell | Georgia | 30076 | United States |
| Chicago Cornea Consultants | Hoffman Estates | Illinois | 60169 | United States |
| Durrie Vision | Overland Park | Kansas | 66211 | United States |
| Kentucky Center for Vision | Lexington | Kentucky | 40509 | United States |
| Tufts Medical Center/ Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care Ltd. | Washington | Missouri | 63090 | United States |
| Raymond Fong MD, PC | New York | New York | 10013 | United States |
| South Shore Eye Care LLP | Wantagh | New York | 11793 | United States |
| SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose | Charlotte | North Carolina | 28210 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Eye Care Associates of Greater Cincinnati | Cincinnati | Ohio | 45236 | United States |
| Mark A. Terry, MD PC/ Devers Eye Institute | Portland | Oregon | 97210 | United States |
| Bluestein Custom Vision | Charleston | South Carolina | 29414 | United States |
| Carolinas Centers for Sight, PC | Florence | South Carolina | 29501 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Keystone Clinical Research | Austin | Texas | 78731 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Medical Center Opth. Assoc. | San Antonio | Texas | 78240 | United States |
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| FG002 | AGN-223575 Dose C | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| FG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
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| ID | Title | Description |
|---|---|---|
| BG000 | AGN-223575 Dose A | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| BG001 | AGN-223575 Dose B | 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| BG002 | AGN-223575 Dose C | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| BG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
| BG004 | Total | Total of all reporting groups |
| 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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| 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 Conjunctival Redness Score in the Study Eye Using a 5-Point Scale | Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement. | Modified Intent-to-treat (mITT) population, consisted of all randomized and treated patients who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. "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, Day 14 |
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| Secondary | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale | OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement. | mITT population, consisted of all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. "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, Day 14 |
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| Secondary | Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale | The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement. | mITT population, consisted of all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. "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, Day 14 |
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| Secondary | Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye | A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness). | Participants from the mITT population, all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. with data available for analysis. | Posted | Number | percentage of participants | Day 14 |
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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 | AGN-223575 Dose A | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. | 1 | 58 | 3 | 58 | ||
| EG001 | AGN-223575 Dose B | 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. | 1 | 59 | 4 | 59 | ||
| EG002 | AGN-223575 Dose C | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. | 1 | 60 | 4 | 60 | ||
| EG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. | 0 | 59 | 6 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA 18.1 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Change from Baseline at Day 14 |
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| OG002 | AGN-223575 Dose C | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| OG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
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| AGN-223575 Dose C |
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| OG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
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| OG003 | AGN-223575 Vehicle | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
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