Trial Outcomes & Findings for A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease (NCT NCT06544694)

Last Updated: 2026-03-27

Results Overview

Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

Day 1 pre-instillation (Baseline), Day 90 post instillation

Results posted on

2026-03-27

Participant Flow

Participants were recruited from 4 investigative sites located in the United States.

This reporting group includes all randomized/treated subjects (80).

Participant milestones

Participant milestones
Measure	0.003% AR-15512 One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period)	Artificial Tears One drop of artificial tears in each eye twice daily for 90 days (treatment period)
Overall Study STARTED	39	41
Overall Study COMPLETED	36	37
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	0.003% AR-15512 One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period)	Artificial Tears One drop of artificial tears in each eye twice daily for 90 days (treatment period)
Overall Study Physician Decision	0	2
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.003% AR-15512 n=39 Participants One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period)	Artificial Tears n=41 Participants One drop of artificial tears in each eye twice daily for 90 days (treatment period)	Total n=80 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 7.75 • n=56 Participants	63.5 years STANDARD_DEVIATION 11.75 • n=62 Participants	63.6 years STANDARD_DEVIATION 9.94 • n=123 Participants
Sex: Female, Male Female	31 Participants n=56 Participants	28 Participants n=62 Participants	59 Participants n=123 Participants
Sex: Female, Male Male	8 Participants n=56 Participants	13 Participants n=62 Participants	21 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=56 Participants	2 Participants n=62 Participants	5 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=56 Participants	39 Participants n=62 Participants	75 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race/Ethnicity, Customized Asian	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=56 Participants	3 Participants n=62 Participants	7 Participants n=123 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race/Ethnicity, Customized White	33 Participants n=56 Participants	38 Participants n=62 Participants	71 Participants n=123 Participants
Race/Ethnicity, Customized Multi-Racial	1 Participants n=56 Participants	0 Participants n=62 Participants	1 Participants n=123 Participants
Race/Ethnicity, Customized Other	1 Participants n=56 Participants	0 Participants n=62 Participants	1 Participants n=123 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Region of Enrollment United States	39 participants n=56 Participants	41 participants n=62 Participants	80 participants n=123 Participants

PRIMARY outcome

Timeframe: Day 1 pre-instillation (Baseline), Day 90 post instillation

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	0.003% AR-15512 n=36 eyes One drop of 0.003% AR-15512 ophthalmic solution in each eye twice daily for 90 days (treatment period)
Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512	94.61 percent change Standard Error 69.275

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

0.003% AR-15512

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Artificial Tears

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=80 participants at risk AEs that occurred from time of consent until initiation of treatment, including the run-in period	0.003% AR-15512 n=39 participants at risk AEs that occurred during 0.003% AR-15512 treatment period	Artificial Tears n=41 participants at risk AEs that occurred during Artificial Tears treatment period
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/80 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	0.00% 0/39 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	2.4% 1/41 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.

Other adverse events

Other adverse events
Measure	Pretreatment n=80 participants at risk AEs that occurred from time of consent until initiation of treatment, including the run-in period	0.003% AR-15512 n=39 participants at risk AEs that occurred during 0.003% AR-15512 treatment period	Artificial Tears n=41 participants at risk AEs that occurred during Artificial Tears treatment period
General disorders Instillation site erythema	0.00% 0/80 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	5.1% 2/39 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	0.00% 0/41 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.
General disorders Instillation site irritation	1.2% 1/80 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	59.0% 23/39 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	2.4% 1/41 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.
Infections and infestations Nasopharyngitis	1.2% 1/80 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	2.6% 1/39 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.	7.3% 3/41 • Adverse Events (AEs) were collected from time of consent until study exit, approximately 15 weeks (2 weeks of run-in phase followed by 13-week randomized treatment period). 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 study medication.

Additional Information

Scientific Advisor, Clinical Research and Development

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER