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The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
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| Sequence 2 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
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| Sequence 3 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
|
| Sequence 4 | Other | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.003% AR-15512 ophthalmic solution | Drug | Investigational ophthalmic solution administered topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention | Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint. | Up to Day 1 post drop instillation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Pharma | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States | ||
| Vision Institute |
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This reporting group includes all randomized subjects (55).
Participants were recruited from 6 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Tears First, Then 512-RT, 512-COLD, 512-RT-EC, 512-COLD-EC | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| FG001 | Artificial Tears, Then 512-RT-EC, 512-RT, 512-COLD-EC, 512-COLD | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| FG002 | Artificial Tears, Then 512-COLD, 512-COLD-EC, 512-RT, 512-RT-EC | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| FG003 | Artificial Tears, Then 512-COLD-EC, 512-RT-EC, 512-COLD, 512-RT | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set: All subjects who have received at least one dose of artificial tears and one dose of 0.003% AR-15512 instillation variation and who have at least one rating of the Rating Sensation Assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Tears First, Then 512-RT, 512-COLD, 512-RT-EC, 512-COLD-EC | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| BG001 | Artificial Tears, Then 512-RT-EC, 512-RT, 512-COLD-EC, 512-COLD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention | Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint. | Safety Analysis Set: All subjects who received at least one dose of artificial tears or one dose of 0.003% AR-15512. AEs for 0.003% AR-15512 are reported by intervention (all instillation variations combined) as specified in the protocol and statistical analysis plan. | Posted | Number | percentage of subjects | Up to Day 1 post drop instillation |
|
Adverse Events (AEs) were collected from time of consent until study exit, approximately 1 day. AEs for 0.003% AR-15512 are reported by intervention (all instillation variations combined) as specified in the protocol and statistical analysis plan.
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered to be related to the study intervention. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. The safety analysis set included all subjects who have received at least one dose of Artificial Tears or one dose of 0.003% AR-15512.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | AEs occurring from time of consent until initiation of treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Advisor, Clinical Research and Development | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2025 | Mar 13, 2026 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2025 | Feb 23, 2026 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
|
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| Artificial tears | Drug | Commercially available, preservative-free lubricant eye drops administered topically |
|
|
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research, LLC | Smyrna | Tennessee | 37167 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| BG002 | Artificial Tears, Then 512-COLD, 512-COLD-EC, 512-RT, 512-RT-EC | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| BG003 | Artificial Tears, Then 512-COLD-EC, 512-RT-EC, 512-COLD, 512-RT | Each instillation consisted of one drop in one eye only starting with artificial tears in the right eye, then alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| 0.003% AR-15512 |
Investigational ophthalmic solution administered topically |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Artificial Tears | Commercially available, preservative-free lubricant eye drops administered topic.. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG002 | 0.003% AR-15512 | Investigational ophthalmic solution administered topically, reported by intervention (all instillation variations combined) as specified in the protocol and statistical analysis plan | 0 | 55 | 0 | 55 | 0 | 55 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |