Dry Eye Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.
Detailed description
At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study. Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.
Interventions
Active ingredients administered via topical ocular instillation
Inactive ingredients administered via topical ocular instillation
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit. * Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit. * Corrected visual acuity as specified in the protocol at the Baseline visit. * Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit. Key
Exclusion criteria
* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety. * Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation. * Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study. * Use of medications as specified in the protocol. * Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Hematology by Visit - Leukocyte Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Leukocyte level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Hemoglobin Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome. |
| Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Day 1 post-treatment, up to Day 365 | A treatment-emergent adverse event was defined as any event that occurred or worsened on or after the day randomized study intervention was initiated. At each study visit, subjects were verbally asked by clinic staff to report any changes to any aspect of their ocular health. Ocular treatment-emergent adverse events reported by the subject or observed by the investigator were summarized by preferred term for overall incidence calculation. This was a subject-based assessment. |
| Mean Change From Baseline in Heart Rate at Each Study Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Heart rate was measured using manual or automated methods and recorded in beats per minute (bpm). Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Systolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Diastolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365 | Baseline (Day 1 pretreatment), Day 365 | Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A negative change from baseline represents a less desirable outcome. |
| Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit | Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit) | Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A decrease from baseline represents a less desirable outcome. |
| Mean Change From Baseline in Hematology by Visit - Basophil Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Basophil level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. The basophils to leukocytes ratio was reported as the absolute number of basophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Eosinophil Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Eosinophil level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. The eosinophils to leukocytes ratio was reported as the absolute number of eosinophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin concentration level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular volume was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Erythrocyte Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte distribution width was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Hematocrit Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Hematocrit level was reported as the volume of red blood cells in liters (L) divided by the volume of blood in L. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Lymphocyte Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Lymphocyte level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. The lymphocytes to leukocytes ratio was reported as the absolute number of lymphocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Monocyte Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Monocyte level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. The monocytes to leukocytes ratio was reported as the absolute number of monocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Neutrophil Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Neutrophil level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. The neutrophils to leukocytes ratio was reported as the absolute number of neutrophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Platelet Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Platelet level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Platelet volume was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Alanine aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Albumin Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Albumin level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Alkaline phosphatase level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Aspartate aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Calcium Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Calcium level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Creatinine Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Creatinine level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Globulin Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Globulin level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Potassium Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Potassium level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Protein Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Protein level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Sodium Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Sodium level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Triglyceride Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Triglyceride level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Urea nitrogen level was measured. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of blood was collected and sent to a laboratory for analysis. Specific gravity level was calculated by dividing the sample's density by the density of water. Minimal change from the start of the study indicates a better outcome. |
| Mean Change From Baseline in Urinalysis by Visit - pH Level | Baseline (Day 1 pretreatment), Day 180, Day 365 | A small volume of urine was collected and sent to a laboratory for analysis. The pH scale ranges from 0 (most acidic) to 14 (most alkaline), with 7 as neutral. Minimal change from the start of the study indicates a better outcome. |
| Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Baseline (Day 1 pretreatment), Day 365 | Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. ETDRS letter scores range from 0 to 100, with each letter correctly identified representing a score of 1. A perfect score of 100 is achieved when all 70 letters on the chart are correctly identified. 85 letters correctly identified corresponds to normal distance eyesight. |
| Mean Corrected Visual Acuity in LogMar by Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. The overall letter score was converted to Logarithmic minimum angle of resolution (LogMAR). LogMAR scores typically range from -0.3 to 1.0, where zero represents normal vision, negative values indicate better than normal vision, and positive values indicate poorer than normal vision. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid erythema (redness of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid edema (swelling of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva hyperemia (increased amount of blood in the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva edema (swelling of the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea staining/erosion were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea edema (swelling of the cornea) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cells in the anterior chamber (the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to anterior chamber flare (a visible clouding of the the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lens opacity (a clouding of the eye's natural lens) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Mean Total Ocular Staining Score by Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Total corneal (fluorescein) staining score ranges between 0 and 5. Total conjunctival staining score is collected as the sum of lissamine green staining nasal and temporal scores and ranges between 0 and 10 per eye. Total ocular staining score is collected as the sum of total corneal and conjunctival scores (0 to 15) with a maximum possible score of 15 per eye. A higher total score indicates greater staining (or worse condition). |
| Mean Intraocular Pressure by Visit | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | Intraocular pressure was measured using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). Values between 10mmHg and 20mmHg are considered normal eye pressure. |
| Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the vitreous (the clear gel that fills the space between the lens and the retina of the eyeball) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the retina (the light-sensitive tissue lining the back of the eye that converts light into electrical signals the brain then interprets as images) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the macula (the round area at the center of the retina that provides central vision) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the optic nerve (the nerve that transmits visual information from the retina to the brain) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
| Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365 | An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the choroid (the layer of blood vessels and connective tissue between the white of the eye and retina) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 10 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all subjects who signed an informed consent and met all eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| 0.003% AR-15512 0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days | 182 |
| AR-15512 Vehicle AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days | 93 |
| Total | 275 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 |
| Overall Study | Disallowed Concurrent Treatment | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 1 |
| Overall Study | Non-compliance | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
| Overall Study | Withdrawal of Consent | 19 | 10 |
Baseline characteristics
| Characteristic | 0.003% AR-15512 | AR-15512 Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 14.46 | 59.1 years STANDARD_DEVIATION 15.42 | 60.5 years STANDARD_DEVIATION 14.79 |
| Age, Customized 18-29 years | 5 subjects | 4 subjects | 9 subjects |
| Age, Customized 30 to 45 years | 23 subjects | 16 subjects | 39 subjects |
| Age, Customized 46-60 years | 44 subjects | 23 subjects | 67 subjects |
| Age, Customized 61-75 years | 81 subjects | 42 subjects | 123 subjects |
| Age, Customized Greater than 75 years | 29 subjects | 8 subjects | 37 subjects |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 21 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 72 Participants | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 subjects | 0 subjects | 2 subjects |
| Race/Ethnicity, Customized Asian | 16 subjects | 10 subjects | 26 subjects |
| Race/Ethnicity, Customized Black or African American | 23 subjects | 14 subjects | 37 subjects |
| Race/Ethnicity, Customized Multi-racial | 0 subjects | 0 subjects | 0 subjects |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 subjects | 0 subjects | 1 subjects |
| Race/Ethnicity, Customized Other | 2 subjects | 2 subjects | 4 subjects |
| Race/Ethnicity, Customized White | 138 subjects | 67 subjects | 205 subjects |
| Sex: Female, Male Female | 130 Participants | 65 Participants | 195 Participants |
| Sex: Female, Male Male | 52 Participants | 28 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 182 | 0 / 0 | 0 / 93 |
| other Total, other adverse events | 90 / 182 | 0 / 182 | 7 / 93 | 0 / 93 |
| serious Total, serious adverse events | 1 / 182 | 6 / 182 | 2 / 93 | 6 / 93 |
Outcome results
Primary
Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. ETDRS letter scores range from 0 to 100, with each letter correctly identified representing a score of 1. A perfect score of 100 is achieved when all 70 letters on the chart are correctly identified. 85 letters correctly identified corresponds to normal distance eyesight.
Time frame: Baseline (Day 1 pretreatment), Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Baseline | 84.9 letter | Standard Deviation 5.38 |
| 0.003% AR-15512 | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Day 365 | 85.1 letter | Standard Deviation 6.23 |
| AR-15512 Vehicle | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Day 365 | 84.6 letter | Standard Deviation 7.15 |
| AR-15512 Vehicle | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Baseline | 84.7 letter | Standard Deviation 6.05 |
| AR-15512 Vehicle - Right Eye | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Baseline | 85.8 letter | Standard Deviation 5.19 |
| AR-15512 Vehicle - Right Eye | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Day 365 | 84.9 letter | Standard Deviation 5.89 |
| AR-15512 Vehicle - Left Eye | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Baseline | 84.9 letter | Standard Deviation 5.91 |
| AR-15512 Vehicle - Left Eye | Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit | Day 365 | 84.1 letter | Standard Deviation 5.9 |
Primary
Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level
A small volume of blood was collected and sent to a laboratory for analysis. Alanine aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level | Change from Baseline at Day 180 | 0.3 units per liter (U/L) | Standard Deviation 15.01 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level | Change from Baseline at Day 365 | -0.2 units per liter (U/L) | Standard Deviation 13.38 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level | Change from Baseline at Day 180 | -2.5 units per liter (U/L) | Standard Deviation 12.11 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level | Change from Baseline at Day 365 | -1.4 units per liter (U/L) | Standard Deviation 12.59 |
Primary
Mean Change From Baseline in Chemistry by Visit - Albumin Level
A small volume of blood was collected and sent to a laboratory for analysis. Albumin level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Albumin Level | Change from Baseline at Day 180 | -2.0 g/L | Standard Deviation 2.37 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Albumin Level | Change from Baseline at Day 365 | -2.1 g/L | Standard Deviation 2.35 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Albumin Level | Change from Baseline at Day 180 | -1.9 g/L | Standard Deviation 2.56 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Albumin Level | Change from Baseline at Day 365 | -2.1 g/L | Standard Deviation 2.3 |
Primary
Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level
A small volume of blood was collected and sent to a laboratory for analysis. Alkaline phosphatase level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level | Change from Baseline at Day 180 | 2.5 U/L | Standard Deviation 13.12 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level | Change from Baseline at Day 365 | -1.3 U/L | Standard Deviation 16.12 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level | Change from Baseline at Day 180 | 0.4 U/L | Standard Deviation 16.66 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level | Change from Baseline at Day 365 | -3.5 U/L | Standard Deviation 13.59 |
Primary
Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level
A small volume of blood was collected and sent to a laboratory for analysis. Aspartate aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level | Change from Baseline at Day 180 | 0.6 U/L | Standard Deviation 14.74 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level | Change from Baseline at Day 365 | 0.0 U/L | Standard Deviation 11.98 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level | Change from Baseline at Day 180 | -0.1 U/L | Standard Deviation 7.8 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level | Change from Baseline at Day 365 | 0.1 U/L | Standard Deviation 9.39 |
Primary
Mean Change From Baseline in Chemistry by Visit - Calcium Level
A small volume of blood was collected and sent to a laboratory for analysis. Calcium level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Calcium Level | Change from Baseline at Day 180 | -0.044 millimoles per liter (mmol/L) | Standard Deviation 0.1051 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Calcium Level | Change from Baseline at Day 365 | -0.049 millimoles per liter (mmol/L) | Standard Deviation 0.1114 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Calcium Level | Change from Baseline at Day 180 | -0.037 millimoles per liter (mmol/L) | Standard Deviation 0.1026 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Calcium Level | Change from Baseline at Day 365 | -0.055 millimoles per liter (mmol/L) | Standard Deviation 0.0923 |
Primary
Mean Change From Baseline in Chemistry by Visit - Creatinine Level
A small volume of blood was collected and sent to a laboratory for analysis. Creatinine level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Creatinine Level | Change from Baseline at Day 180 | 1.3 micromoles per liter (Umol/L) | Standard Deviation 13.69 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Creatinine Level | Change from Baseline at Day 365 | 6.0 micromoles per liter (Umol/L) | Standard Deviation 60.26 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Creatinine Level | Change from Baseline at Day 180 | -0.2 micromoles per liter (Umol/L) | Standard Deviation 12.38 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Creatinine Level | Change from Baseline at Day 365 | 1.3 micromoles per liter (Umol/L) | Standard Deviation 10 |
Primary
Mean Change From Baseline in Chemistry by Visit - Globulin Level
A small volume of blood was collected and sent to a laboratory for analysis. Globulin level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Globulin Level | Change from Baseline at Day 180 | 0.3 g/L | Standard Deviation 2.61 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Globulin Level | Change from Baseline at Day 365 | 0.0 g/L | Standard Deviation 2.43 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Globulin Level | Change from Baseline at Day 180 | 0.5 g/L | Standard Deviation 2.44 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Globulin Level | Change from Baseline at Day 365 | -0.1 g/L | Standard Deviation 2.05 |
Primary
Mean Change From Baseline in Chemistry by Visit - Potassium Level
A small volume of blood was collected and sent to a laboratory for analysis. Potassium level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Potassium Level | Change from Baseline at Day 180 | 0.09 mmol/L | Standard Deviation 0.492 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Potassium Level | Change from Baseline at Day 365 | 0.06 mmol/L | Standard Deviation 0.47 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Potassium Level | Change from Baseline at Day 180 | 0.11 mmol/L | Standard Deviation 0.482 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Potassium Level | Change from Baseline at Day 365 | 0.16 mmol/L | Standard Deviation 0.704 |
Primary
Mean Change From Baseline in Chemistry by Visit - Protein Level
A small volume of blood was collected and sent to a laboratory for analysis. Protein level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Protein Level | Change from Baseline at Day 180 | -1.7 g/L | Standard Deviation 4.19 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Protein Level | Change from Baseline at Day 365 | -2.1 g/L | Standard Deviation 3.97 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Protein Level | Change from Baseline at Day 180 | -1.4 g/L | Standard Deviation 4.15 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Protein Level | Change from Baseline at Day 365 | -2.2 g/L | Standard Deviation 3.67 |
Primary
Mean Change From Baseline in Chemistry by Visit - Sodium Level
A small volume of blood was collected and sent to a laboratory for analysis. Sodium level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Sodium Level | Change from Baseline at Day 180 | 0.0 mmol/L | Standard Deviation 2.46 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Sodium Level | Change from Baseline at Day 365 | 0.4 mmol/L | Standard Deviation 2.36 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Sodium Level | Change from Baseline at Day 180 | -0.1 mmol/L | Standard Deviation 2.17 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Sodium Level | Change from Baseline at Day 365 | 0.5 mmol/L | Standard Deviation 2.11 |
Primary
Mean Change From Baseline in Chemistry by Visit - Triglyceride Level
A small volume of blood was collected and sent to a laboratory for analysis. Triglyceride level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Triglyceride Level | Change from Baseline at Day 180 | 0.079 mmol/L | Standard Deviation 1.1354 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Triglyceride Level | Change from Baseline at Day 365 | -0.024 mmol/L | Standard Deviation 0.9164 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Triglyceride Level | Change from Baseline at Day 180 | -0.276 mmol/L | Standard Deviation 1.1943 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Triglyceride Level | Change from Baseline at Day 365 | -0.120 mmol/L | Standard Deviation 1.2344 |
Primary
Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level
A small volume of blood was collected and sent to a laboratory for analysis. Urea nitrogen level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level | Change from Baseline at Day 180 | 0.22 mmol/L | Standard Deviation 2.066 |
| 0.003% AR-15512 | Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level | Change from Baseline at Day 365 | 0.16 mmol/L | Standard Deviation 2.372 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level | Change from Baseline at Day 180 | 0.06 mmol/L | Standard Deviation 1.889 |
| AR-15512 Vehicle | Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level | Change from Baseline at Day 365 | 0.044 mmol/L | Standard Deviation 1.637 |
Primary
Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit
Diastolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 90 | 0.2 mmHg | Standard Deviation 9.73 |
| 0.003% AR-15512 | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 270 | 0.8 mmHg | Standard Deviation 9.63 |
| 0.003% AR-15512 | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 14 | 1.7 mmHg | Standard Deviation 9.29 |
| 0.003% AR-15512 | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 365 | 1.4 mmHg | Standard Deviation 9.56 |
| 0.003% AR-15512 | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 180 | 1.1 mmHg | Standard Deviation 9.01 |
| AR-15512 Vehicle | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 365 | 1.3 mmHg | Standard Deviation 9.23 |
| AR-15512 Vehicle | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 180 | 1.6 mmHg | Standard Deviation 9.96 |
| AR-15512 Vehicle | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 14 | 0.6 mmHg | Standard Deviation 9.81 |
| AR-15512 Vehicle | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 270 | 0.5 mmHg | Standard Deviation 9.83 |
| AR-15512 Vehicle | Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit | Change from Baseline at Day 90 | 1.1 mmHg | Standard Deviation 9.63 |
Primary
Mean Change From Baseline in Heart Rate at Each Study Visit
Heart rate was measured using manual or automated methods and recorded in beats per minute (bpm). Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 90 | 1.4 beats per minute | Standard Deviation 9.04 |
| 0.003% AR-15512 | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 270 | 0.8 beats per minute | Standard Deviation 9.57 |
| 0.003% AR-15512 | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 180 | 0.5 beats per minute | Standard Deviation 9.2 |
| 0.003% AR-15512 | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 365 | 1.1 beats per minute | Standard Deviation 9.73 |
| 0.003% AR-15512 | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 14 | 0.7 beats per minute | Standard Deviation 9.06 |
| AR-15512 Vehicle | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 365 | 1.0 beats per minute | Standard Deviation 10 |
| AR-15512 Vehicle | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 14 | 0.6 beats per minute | Standard Deviation 8.51 |
| AR-15512 Vehicle | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 90 | 1.7 beats per minute | Standard Deviation 10.93 |
| AR-15512 Vehicle | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 180 | -0.9 beats per minute | Standard Deviation 9.71 |
| AR-15512 Vehicle | Mean Change From Baseline in Heart Rate at Each Study Visit | Change from Baseline at Day 270 | 0.5 beats per minute | Standard Deviation 9.34 |
Primary
Mean Change From Baseline in Hematology by Visit - Basophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Basophil level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Basophil Level | Change from Baseline at Day 180 | 0.00 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.057 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Basophil Level | Change from Baseline at Day 365 | -0.01 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.053 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Basophil Level | Change from Baseline at Day 180 | -0.01 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.052 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Basophil Level | Change from Baseline at Day 365 | -0.01 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.048 |
Primary
Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The basophils to leukocytes ratio was reported as the absolute number of basophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 0.03 percentage of cells | Standard Deviation 0.256 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | -0.05 percentage of cells | Standard Deviation 0.217 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 0.02 percentage of cells | Standard Deviation 0.291 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | -0.02 percentage of cells | Standard Deviation 0.238 |
Primary
Mean Change From Baseline in Hematology by Visit - Eosinophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Eosinophil level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Eosinophil Level | Change from Baseline at Day 180 | 0.02 10^9 cells/L | Standard Deviation 0.143 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Eosinophil Level | Change from Baseline at Day 365 | 0.02 10^9 cells/L | Standard Deviation 0.15 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Eosinophil Level | Change from Baseline at Day 180 | 0.01 10^9 cells/L | Standard Deviation 0.084 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Eosinophil Level | Change from Baseline at Day 365 | 0.00 10^9 cells/L | Standard Deviation 0.076 |
Primary
Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The eosinophils to leukocytes ratio was reported as the absolute number of eosinophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 0.29 percentage of cells | Standard Deviation 1.626 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 0.34 percentage of cells | Standard Deviation 2.081 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 0.20 percentage of cells | Standard Deviation 1.468 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 0.13 percentage of cells | Standard Deviation 1.333 |
Primary
Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte distribution width was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells | Change from Baseline at Day 180 | 0.09 percentage of variation of cells | Standard Deviation 1.038 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells | Change from Baseline at Day 365 | -0.02 percentage of variation of cells | Standard Deviation 0.924 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells | Change from Baseline at Day 180 | 0.13 percentage of variation of cells | Standard Deviation 0.721 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells | Change from Baseline at Day 365 | -0.17 percentage of variation of cells | Standard Deviation 0.666 |
Primary
Mean Change From Baseline in Hematology by Visit - Erythrocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Level | Change from Baseline at Day 180 | -0.071 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2858 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Level | Change from Baseline at Day 365 | -0.073 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2873 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Level | Change from Baseline at Day 180 | -0.036 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2738 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Level | Change from Baseline at Day 365 | -0.076 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2347 |
Primary
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin concentration level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level | Change from Baseline at Day 180 | -2.0 grams per liter (g/L) | Standard Deviation 9.45 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level | Change from Baseline at Day 365 | 1.2 grams per liter (g/L) | Standard Deviation 8.76 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level | Change from Baseline at Day 180 | -1.3 grams per liter (g/L) | Standard Deviation 8.71 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level | Change from Baseline at Day 365 | 0.9 grams per liter (g/L) | Standard Deviation 9.74 |
Primary
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level | Change from Baseline at Day 180 | -0.01 picograms (pg) | Standard Deviation 1.02 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level | Change from Baseline at Day 365 | 0.21 picograms (pg) | Standard Deviation 0.877 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level | Change from Baseline at Day 180 | 0.01 picograms (pg) | Standard Deviation 0.609 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level | Change from Baseline at Day 365 | 0.26 picograms (pg) | Standard Deviation 0.905 |
Primary
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular volume was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume | Change from Baseline at Day 180 | 0.53 femtoliters (fL) | Standard Deviation 2.996 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume | Change from Baseline at Day 365 | 0.28 femtoliters (fL) | Standard Deviation 2.449 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume | Change from Baseline at Day 180 | 0.33 femtoliters (fL) | Standard Deviation 2.548 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume | Change from Baseline at Day 365 | 0.50 femtoliters (fL) | Standard Deviation 2.684 |
Primary
Mean Change From Baseline in Hematology by Visit - Hematocrit Level
A small volume of blood was collected and sent to a laboratory for analysis. Hematocrit level was reported as the volume of red blood cells in liters (L) divided by the volume of blood in L. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Hematocrit Level | Change from Baseline at Day 180 | -0.0038 proportion | Standard Deviation 0.02449 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Hematocrit Level | Change from Baseline at Day 365 | -0.0053 proportion | Standard Deviation 0.02723 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Hematocrit Level | Change from Baseline at Day 180 | -0.0020 proportion | Standard Deviation 0.0258 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Hematocrit Level | Change from Baseline at Day 365 | -0.0051 proportion | Standard Deviation 0.02443 |
Primary
Mean Change From Baseline in Hematology by Visit - Hemoglobin Level
A small volume of blood was collected and sent to a laboratory for analysis. Hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Hemoglobin Level | Change from Baseline at Day 180 | -2.1 g/L | Standard Deviation 7.94 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Hemoglobin Level | Change from Baseline at Day 365 | -1.3 g/L | Standard Deviation 8.69 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Hemoglobin Level | Change from Baseline at Day 180 | -1.1 g/L | Standard Deviation 8.38 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Hemoglobin Level | Change from Baseline at Day 365 | -1.3 g/L | Standard Deviation 7.91 |
Primary
Mean Change From Baseline in Hematology by Visit - Leukocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Leukocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Leukocyte Level | Change from Baseline at Day 180 | -0.06 10^9 cells/L | Standard Deviation 1.653 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Leukocyte Level | Change from Baseline at Day 365 | -0.12 10^9 cells/L | Standard Deviation 1.351 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Leukocyte Level | Change from Baseline at Day 180 | -0.46 10^9 cells/L | Standard Deviation 1.054 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Leukocyte Level | Change from Baseline at Day 365 | -0.38 10^9 cells/L | Standard Deviation 1.342 |
Primary
Mean Change From Baseline in Hematology by Visit - Lymphocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Lymphocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Lymphocyte Level | Change from Baseline at Day 180 | -0.28 10^9 cells/L | Standard Deviation 0.5 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Lymphocyte Level | Change from Baseline at Day 365 | -0.18 10^9 cells/L | Standard Deviation 0.417 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Lymphocyte Level | Change from Baseline at Day 180 | -0.28 10^9 cells/L | Standard Deviation 0.522 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Lymphocyte Level | Change from Baseline at Day 365 | -0.32 10^9 cells/L | Standard Deviation 0.466 |
Primary
Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The lymphocytes to leukocytes ratio was reported as the absolute number of lymphocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | -3.21 percentage of cells | Standard Deviation 6.934 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | -1.95 percentage of cells | Standard Deviation 6.664 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | -1.76 percentage of cells | Standard Deviation 6.713 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | -2.20 percentage of cells | Standard Deviation 6.544 |
Primary
Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume
A small volume of blood was collected and sent to a laboratory for analysis. Platelet volume was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume | Change from Baseline at Day 180 | -0.24 fL | Standard Deviation 0.511 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume | Change from Baseline at Day 365 | -0.04 fL | Standard Deviation 0.479 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume | Change from Baseline at Day 180 | -0.15 fL | Standard Deviation 0.559 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume | Change from Baseline at Day 365 | -0.24 fL | Standard Deviation 0.433 |
Primary
Mean Change From Baseline in Hematology by Visit - Monocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Monocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Monocyte Level | Change from Baseline at Day 180 | -0.02 10^9 cells/L | Standard Deviation 0.148 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Monocyte Level | Change from Baseline at Day 365 | -0.01 10^9 cells/L | Standard Deviation 0.167 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Monocyte Level | Change from Baseline at Day 180 | -0.03 10^9 cells/L | Standard Deviation 0.145 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Monocyte Level | Change from Baseline at Day 365 | -0.01 10^9 cells/L | Standard Deviation 0.185 |
Primary
Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The monocytes to leukocytes ratio was reported as the absolute number of monocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | -0.10 percentage of cells | Standard Deviation 2.1 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 0.09 percentage of cells | Standard Deviation 2.182 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 0.21 percentage of cells | Standard Deviation 2.005 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 0.25 percentage of cells | Standard Deviation 2.04 |
Primary
Mean Change From Baseline in Hematology by Visit - Neutrophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Neutrophil level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Neutrophil Level | Change from Baseline at Day 180 | 0.20 10^9 cells/L | Standard Deviation 1.532 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Neutrophil Level | Change from Baseline at Day 365 | 0.05 10^9 cells/L | Standard Deviation 1.208 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Neutrophil Level | Change from Baseline at Day 180 | -0.17 10^9 cells/L | Standard Deviation 0.912 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Neutrophil Level | Change from Baseline at Day 365 | -0.05 10^9 cells/L | Standard Deviation 1.197 |
Primary
Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The neutrophils to leukocytes ratio was reported as the absolute number of neutrophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 3.00 percentage of cells | Standard Deviation 8.231 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 1.58 percentage of cells | Standard Deviation 8.055 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 180 | 1.32 percentage of cells | Standard Deviation 8.546 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Change from Baseline at Day 365 | 1.84 percentage of cells | Standard Deviation 7.839 |
Primary
Mean Change From Baseline in Hematology by Visit - Platelet Level
A small volume of blood was collected and sent to a laboratory for analysis. Platelet level was measured. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Platelet Level | Change from Baseline at Day 180 | -3.9 10^9 cells/L | Standard Deviation 42.18 |
| 0.003% AR-15512 | Mean Change From Baseline in Hematology by Visit - Platelet Level | Change from Baseline at Day 365 | -3.7 10^9 cells/L | Standard Deviation 32.58 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Platelet Level | Change from Baseline at Day 180 | -9.0 10^9 cells/L | Standard Deviation 40.42 |
| AR-15512 Vehicle | Mean Change From Baseline in Hematology by Visit - Platelet Level | Change from Baseline at Day 365 | -1.5 10^9 cells/L | Standard Deviation 39.96 |
Primary
Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A negative change from baseline represents a less desirable outcome.
Time frame: Baseline (Day 1 pretreatment), Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365 | 12.8 cells/mm^2 | Standard Deviation 204.06 |
| AR-15512 Vehicle | Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365 | 32.4 cells/mm^2 | Standard Deviation 203.12 |
| AR-15512 Vehicle - Right Eye | Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365 | -40.4 cells/mm^2 | Standard Deviation 172.29 |
| AR-15512 Vehicle - Left Eye | Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365 | -15.7 cells/mm^2 | Standard Deviation 162.02 |
Primary
Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit
Systolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 90 | 0.0 mmHg | Standard Deviation 14.27 |
| 0.003% AR-15512 | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 270 | -1.3 mmHg | Standard Deviation 14.98 |
| 0.003% AR-15512 | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 180 | -3.3 mmHg | Standard Deviation 15.23 |
| 0.003% AR-15512 | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 365 | 0.1 mmHg | Standard Deviation 16.25 |
| 0.003% AR-15512 | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 14 | 1.4 mmHg | Standard Deviation 16.62 |
| AR-15512 Vehicle | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 365 | -0.3 mmHg | Standard Deviation 13.65 |
| AR-15512 Vehicle | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 14 | 1.7 mmHg | Standard Deviation 14.4 |
| AR-15512 Vehicle | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 90 | 1.2 mmHg | Standard Deviation 14.65 |
| AR-15512 Vehicle | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 180 | 0.1 mmHg | Standard Deviation 17.19 |
| AR-15512 Vehicle | Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit | Change from Baseline at Day 270 | -1.8 mmHg | Standard Deviation 16.38 |
Primary
Mean Change From Baseline in Urinalysis by Visit - pH Level
A small volume of urine was collected and sent to a laboratory for analysis. The pH scale ranges from 0 (most acidic) to 14 (most alkaline), with 7 as neutral. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Urinalysis by Visit - pH Level | Change from Baseline at Day 180 | 0.06 pH | Standard Deviation 0.882 |
| 0.003% AR-15512 | Mean Change From Baseline in Urinalysis by Visit - pH Level | Change from Baseline at Day 365 | 0.05 pH | Standard Deviation 0.712 |
| AR-15512 Vehicle | Mean Change From Baseline in Urinalysis by Visit - pH Level | Change from Baseline at Day 180 | -0.02 pH | Standard Deviation 0.857 |
| AR-15512 Vehicle | Mean Change From Baseline in Urinalysis by Visit - pH Level | Change from Baseline at Day 365 | 0.03 pH | Standard Deviation 0.769 |
Primary
Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level
A small volume of blood was collected and sent to a laboratory for analysis. Specific gravity level was calculated by dividing the sample's density by the density of water. Minimal change from the start of the study indicates a better outcome.
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level | Change from Baseline at Day 180 | 0.0005 ratio | Standard Deviation 0.00783 |
| 0.003% AR-15512 | Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level | Change from Baseline at Day 365 | 0.0007 ratio | Standard Deviation 0.00886 |
| AR-15512 Vehicle | Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level | Change from Baseline at Day 180 | 0.0020 ratio | Standard Deviation 0.00713 |
| AR-15512 Vehicle | Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level | Change from Baseline at Day 365 | 0.0019 ratio | Standard Deviation 0.00732 |
Primary
Mean Corrected Visual Acuity in LogMar by Visit
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. The overall letter score was converted to Logarithmic minimum angle of resolution (LogMAR). LogMAR scores typically range from -0.3 to 1.0, where zero represents normal vision, negative values indicate better than normal vision, and positive values indicate poorer than normal vision.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Day 365 | 0.063 logMAR | Standard Deviation 0.1183 |
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Day 180 | 0.047 logMAR | Standard Deviation 0.1304 |
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Baseline | 0.062 logMAR | Standard Deviation 0.1326 |
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Day 90 | 0.046 logMAR | Standard Deviation 0.1315 |
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Day 270 | 0.076 logMAR | Standard Deviation 0.1364 |
| 0.003% AR-15512 | Mean Corrected Visual Acuity in LogMar by Visit | Day 14 | 0.055 logMAR | Standard Deviation 0.1386 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Day 270 | 0.070 logMAR | Standard Deviation 0.1288 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Day 365 | 0.060 logMAR | Standard Deviation 0.1244 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Day 14 | 0.053 logMAR | Standard Deviation 0.1406 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Baseline | 0.061 logMAR | Standard Deviation 0.1339 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Day 90 | 0.044 logMAR | Standard Deviation 0.1279 |
| AR-15512 Vehicle | Mean Corrected Visual Acuity in LogMar by Visit | Day 180 | 0.045 logMAR | Standard Deviation 0.1298 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 14 | 0.048 logMAR | Standard Deviation 0.1334 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 270 | 0.065 logMAR | Standard Deviation 0.1461 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 180 | 0.042 logMAR | Standard Deviation 0.1523 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Baseline | 0.064 logMAR | Standard Deviation 0.1433 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 365 | 0.080 logMAR | Standard Deviation 0.1523 |
| AR-15512 Vehicle - Right Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 90 | 0.048 logMAR | Standard Deviation 0.1339 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 365 | 0.084 logMAR | Standard Deviation 0.146 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Baseline | 0.080 logMAR | Standard Deviation 0.1435 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 14 | 0.053 logMAR | Standard Deviation 0.1481 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 180 | 0.051 logMAR | Standard Deviation 0.1548 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 270 | 0.092 logMAR | Standard Deviation 0.1458 |
| AR-15512 Vehicle - Left Eye | Mean Corrected Visual Acuity in LogMar by Visit | Day 90 | 0.049 logMAR | Standard Deviation 0.1268 |
Primary
Mean Intraocular Pressure by Visit
Intraocular pressure was measured using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). Values between 10mmHg and 20mmHg are considered normal eye pressure.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | Day 365 | 15.4 mmHg | Standard Deviation 2.55 |
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | Day 180 | 15.5 mmHg | Standard Deviation 2.62 |
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | Day 14 | 15.5 mmHg | Standard Deviation 2.82 |
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | 9Day 90 | 15.6 mmHg | Standard Deviation 2.52 |
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | Day 270 | 15.3 mmHg | Standard Deviation 2.66 |
| 0.003% AR-15512 | Mean Intraocular Pressure by Visit | Baseline | 15.4 mmHg | Standard Deviation 2.48 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | Day 270 | 15.5 mmHg | Standard Deviation 2.49 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | Day 365 | 15.4 mmHg | Standard Deviation 2.77 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | Day 14 | 15.6 mmHg | Standard Deviation 2.85 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | Baseline | 15.6 mmHg | Standard Deviation 2.57 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | 9Day 90 | 15.5 mmHg | Standard Deviation 2.61 |
| AR-15512 Vehicle | Mean Intraocular Pressure by Visit | Day 180 | 15.7 mmHg | Standard Deviation 2.62 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | Baseline | 15.5 mmHg | Standard Deviation 2.75 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | Day 14 | 15.6 mmHg | Standard Deviation 2.81 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | Day 270 | 15.1 mmHg | Standard Deviation 2.79 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | Day 180 | 14.8 mmHg | Standard Deviation 2.68 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | Day 365 | 15.4 mmHg | Standard Deviation 3.15 |
| AR-15512 Vehicle - Right Eye | Mean Intraocular Pressure by Visit | 9Day 90 | 15.2 mmHg | Standard Deviation 2.72 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | Day 365 | 15.5 mmHg | Standard Deviation 3.06 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | Baseline | 15.6 mmHg | Standard Deviation 2.71 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | Day 14 | 15.5 mmHg | Standard Deviation 2.86 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | 9Day 90 | 15.0 mmHg | Standard Deviation 2.86 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | Day 180 | 14.8 mmHg | Standard Deviation 2.66 |
| AR-15512 Vehicle - Left Eye | Mean Intraocular Pressure by Visit | Day 270 | 15.2 mmHg | Standard Deviation 2.98 |
Primary
Mean Total Ocular Staining Score by Visit
Total corneal (fluorescein) staining score ranges between 0 and 5. Total conjunctival staining score is collected as the sum of lissamine green staining nasal and temporal scores and ranges between 0 and 10 per eye. Total ocular staining score is collected as the sum of total corneal and conjunctival scores (0 to 15) with a maximum possible score of 15 per eye. A higher total score indicates greater staining (or worse condition).
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Day 180 | 2.74 score on a scale | Standard Deviation 2.493 |
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Day 14 | 3.46 score on a scale | Standard Deviation 2.339 |
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Day 270 | 2.45 score on a scale | Standard Deviation 2.513 |
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Baseline | 4.08 score on a scale | Standard Deviation 2.167 |
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Day 365 | 2.97 score on a scale | Standard Deviation 2.841 |
| 0.003% AR-15512 | Mean Total Ocular Staining Score by Visit | Day 90 | 2.91 score on a scale | Standard Deviation 2.415 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Day 180 | 2.85 score on a scale | Standard Deviation 2.518 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Baseline | 4.36 score on a scale | Standard Deviation 2.332 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Day 14 | 3.70 score on a scale | Standard Deviation 2.395 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Day 90 | 3.17 score on a scale | Standard Deviation 2.543 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Day 270 | 2.78 score on a scale | Standard Deviation 2.556 |
| AR-15512 Vehicle | Mean Total Ocular Staining Score by Visit | Day 365 | 2.97 score on a scale | Standard Deviation 2.625 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Baseline | 3.77 score on a scale | Standard Deviation 2.163 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Day 90 | 2.97 score on a scale | Standard Deviation 2.674 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Day 365 | 2.89 score on a scale | Standard Deviation 2.619 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Day 270 | 2.53 score on a scale | Standard Deviation 2.524 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Day 180 | 2.65 score on a scale | Standard Deviation 2.477 |
| AR-15512 Vehicle - Right Eye | Mean Total Ocular Staining Score by Visit | Day 14 | 3.45 score on a scale | Standard Deviation 2.368 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Baseline | 4.02 score on a scale | Standard Deviation 2.352 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Day 365 | 3.30 score on a scale | Standard Deviation 2.807 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Day 270 | 2.86 score on a scale | Standard Deviation 2.516 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Day 90 | 3.27 score on a scale | Standard Deviation 2.815 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Day 180 | 3.05 score on a scale | Standard Deviation 2.663 |
| AR-15512 Vehicle - Left Eye | Mean Total Ocular Staining Score by Visit | Day 14 | 3.64 score on a scale | Standard Deviation 2.4 |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cells in the anterior chamber (the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to anterior chamber flare (a visible clouding of the the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva edema (swelling of the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva hyperemia (increased amount of blood in the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Baseline | 2 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 90 | 1 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 270 | 1 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Baseline | 2 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 90 | 1 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 180 | 1 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea edema (swelling of the cornea) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea staining/erosion were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Baseline | 2 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Baseline | 2 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lens opacity (a clouding of the eye's natural lens) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with natural lens intact (phakic) and data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid edema (swelling of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 90 | 1 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Baseline | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Baseline | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 90 | 1 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema | Day 270 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid erythema (redness of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Baseline | 1 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | 88Day 14 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Baseline | 1 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | 88Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | 88Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 270 | 1 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | 88Day 14 | 1 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Baseline | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema | Day 90 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the choroid (the layer of blood vessels and connective tissue between the white of the eye and retina) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the macula (the round area at the center of the retina that provides central vision) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 270 | 1 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 365 | 1 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the optic nerve (the nerve that transmits visual information from the retina to the brain) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
Primary
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the retina (the light-sensitive tissue lining the back of the eye that converts light into electrical signals the brain then interprets as images) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina | Clinically Significant Change from Baseline at Day 365 | 1 subjects |
Primary
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the vitreous (the clear gel that fills the space between the lens and the retina of the eyeball) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| 0.003% AR-15512 | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 270 | 1 subjects |
| AR-15512 Vehicle - Right Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 365 | 1 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 270 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 90 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 14 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 180 | 0 subjects |
| AR-15512 Vehicle - Left Eye | Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous | Clinically Significant Change from Baseline at Day 365 | 0 subjects |
Primary
Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent
A treatment-emergent adverse event was defined as any event that occurred or worsened on or after the day randomized study intervention was initiated. At each study visit, subjects were verbally asked by clinic staff to report any changes to any aspect of their ocular health. Ocular treatment-emergent adverse events reported by the subject or observed by the investigator were summarized by preferred term for overall incidence calculation. This was a subject-based assessment.
Time frame: Day 1 post-treatment, up to Day 365
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.003% AR-15512 | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Instillation site pain | 90 adverse event |
| 0.003% AR-15512 | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Eye pruritis | 2 adverse event |
| 0.003% AR-15512 | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Eyelid margin crusting | 1 adverse event |
| AR-15512 Vehicle | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Eyelid margin crusting | 2 adverse event |
| AR-15512 Vehicle | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Instillation site pain | 7 adverse event |
| AR-15512 Vehicle | Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent | Eye pruritis | 3 adverse event |
Primary
Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm\^2). A decrease from baseline represents a less desirable outcome.
Time frame: Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)
Population: Safety Population with data at baseline and corresponding visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.003% AR-15512 | Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit | 3.3 percentage of subjects |
| AR-15512 Vehicle | Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit | 2.6 percentage of subjects |
| AR-15512 Vehicle - Right Eye | Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit | 5.1 percentage of subjects |
| AR-15512 Vehicle - Left Eye | Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit | 2.5 percentage of subjects |