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This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.
At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 visit, subjects will exit the study.
Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.003% AR-15512 | Experimental | 0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days |
|
| AR-15512 Vehicle | Placebo Comparator | AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.003% AR-15512 ophthalmic solution | Drug | Administered via topical ocular instillation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 14 post-drop |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28 | The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scientific Advisor, Clinical R&D | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management, Inc | Glendale | California | 90027 | United States | ||
| Premiere Practice Management, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41038456 | Derived | Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30. |
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This reporting group includes all randomized participants.
Participants were recruited from 23 investigative sites located in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | 0.003% AR-15512 | 0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days |
| FG001 | AR-15512 Vehicle | AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 13, 2022 | Nov 19, 2024 |
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| AR-15512 vehicle ophthalmic solution |
| Drug |
Inactive ingredients administered via topical ocular instillation |
|
| Baseline (Day 1); Day 28 |
| Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 value was compared to the Day 1 value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 14 post-drop |
| Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 1 post-drop |
| Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 1 post-drop |
| Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 90 post-drop |
| Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis. | Baseline (Day 1) pre-drop; Day 90 post-drop |
| Least Squares Mean Change From Baseline in Global SANDE Score on Day 90 | The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes). | Baseline (Day 1); Day 90 |
| Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90 | The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | Baseline (Day 1); Day 90 |
| Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90 | The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | Baseline (Day 1); Day 90 |
| Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90 | The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | Baseline (Day 1); Day 90 |
| Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90 | The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | Baseline (Day 1); Day 90 |
| Torrance |
| California |
| 90505 |
| United States |
| Vision Institute | Colorado Springs | Colorado | 80907 | United States |
| The Eye Care Group | Waterbury | Connecticut | 06708 | United States |
| Segal Drug Trials, Inc. | Delray Beach | Florida | 33484 | United States |
| Michael Washburn Center for Ophthalmic Research, LLC | Indianapolis | Indiana | 46240 | United States |
| Butchertown Clinical Trials | Louisville | Kentucky | 40206 | United States |
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Center for Sight | Henderson | Nevada | 89052 | United States |
| Core, Inc. | Shelby | North Carolina | 28150 | United States |
| Bergstrom Eye Research | Fargo | North Dakota | 58103 | United States |
| Verum Research | Eugene | Oregon | 97401 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16507 | United States |
| Advancing Vision Research | Goodlettsville | Tennessee | 37072 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Advancing Vision Research | Smyrna | Tennessee | 37167 | United States |
| Austin Clinical Research | Austin | Texas | 78750 | United States |
| Valley Retina Institute, PA | Harlingen | Texas | 78550 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Alpine Research Organization Inc. | Clinton | Utah | 84015 | United States |
| ITT Population | All randomized subjects |
|
| Safety Population | All randomized subjects who have received at least one dose of the investigational product |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.003% AR-15512 | 0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 90 days |
| BG001 | AR-15512 Vehicle | AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 90 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Unanesthetized Schirmer Test Pre-Drop at Baseline (Day 1) | Mean | Standard Deviation | milllimeter |
| |||||||||||||||
| Global SANDE Score at Baseline (Day 1) | Mean | Standard Deviation | millimeter |
| |||||||||||||||
| SANDE Frequency Score at Baseline (Day 1) | Mean | Standard Deviation | millimeter |
| |||||||||||||||
| SANDE Severity Score at Baseline (Day 1) | Mean | Standard Deviation | millimeter |
| |||||||||||||||
| Eye Dryness Score at Baseline (Day 1) | Mean | Standard Deviation | millimeter |
| |||||||||||||||
| Ocular Discomfort Score at Baseline (Day 1) | Mean | Standard Deviation | millimeter |
|
| 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 Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Number | percentage of subjects | Baseline (Day 1) pre-drop; Day 14 post-drop | eyes | eyes |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28 | The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes). | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 28 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 value was compared to the Day 1 value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1) pre-drop; Day 14 post-drop | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Number | percentage of subjects | Baseline (Day 1) pre-drop; Day 1 post-drop | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Deviation | millimeter | Baseline (Day 1) pre-drop; Day 1 post-drop | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Number | percentage of subjects | Baseline (Day 1) pre-drop; Day 90 post-drop | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye) | The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1) pre-drop; Day 90 post-drop | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Global SANDE Score on Day 90 | The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes). | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90 | The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 90 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90 | The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 90 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90 | The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90 | The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. | ITT population comprising all randomized subjects. This analysis uses multiple imputation methodology. | Posted | Least Squares Mean | Standard Error | millimeter | Baseline (Day 1); Day 90 |
|
|
An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 15 weeks. The safety population includes all randomized subjects who have received at least one dose of the investigational product. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at Risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at Risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | AEs reported in this group occurred prior to treatment with the study drug and include the 2-week vehicle run-in. | 0 | 465 | 1 | 465 | 4 | 465 |
| EG001 | 0.003% AR-15512 Ocular | AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period. | 0 | 0 | 0 | 230 | 120 | 230 |
| EG002 | 0.003% AR-15512 Nonocular | AEs reported in this group occurred during the 0.003% AR-15512 ophthalmic solution treatment period. | 0 | 230 | 1 | 230 | 0 | 230 |
| EG003 | AR-15512 Vehicle Ocular | AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period. | 0 | 0 | 0 | 235 | 10 | 235 |
| EG004 | AR-15512 Vehicle Nonocular | AEs reported in this group occurred during the AR-15512 vehicle ophthalmic solution treatment period. | 0 | 235 | 6 | 235 | 0 | 235 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA (25.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Advisor, Clinical Research and Development | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2023 | Nov 19, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black / African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
|
| Multi-racial |
|
| Other |
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| Other |
Difference (2-sided) |
For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline. |
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