AR-15512 Ophthalmic Solution (0.003%) for Dry Eye Syndromes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dry Eye Syndromes+3 More
AR-15512 Ophthalmic Solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This will be a 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline (Day 1) visit as well as visits at Day 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit).

Eligible Conditions
  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: Day 1, 14, 90, 180, 270 & 365

Day 1 & 365
Diabetic Retinopathy
Day 1 and 365
Endothelial cell counts
Day 1
Accumulation Ratio (Rcmax)
Minimum Plasma Concentration (Cmin)
Time to Last Detectable Concentration (Tlast)
Time to Maximum Concentration (Tmax)
Total Exposure (AUC0-last)
Day 1
Adverse Events
Ultrasound Biomicroscopy
Blood Pressure
Dilated fundus exam
Intraocular pressure (IOP)
LogMAR Visual Acuity
Staining method
Day 1
Hematology, chemistry, and urinalysis
Day 1
Heart Rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

DuoTrav
6%Ocular hyperaemia
5%Eye pruritus
2%Nasopharyngitis
2%Dry eye
1%Acute tonsillitis
1%Cataract
1%Pharyngitis
1%Eye irritation
1%Eyelids pruritus
1%Ocular surface disease
1%Conjunctivitis allergic
1%Blepharal pigmentation
1%Arthritis
1%Eye pain
1%Hypersensitivity
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02003391) in the DuoTrav ARM group. Side effects include: Ocular hyperaemia with 6%, Eye pruritus with 5%, Nasopharyngitis with 2%, Dry eye with 2%, Acute tonsillitis with 1%.

Trial Design

2 Treatment Groups

AR-15512 Ophthalmic Solution (0.003%)
1 of 2
Vehicle
1 of 2
Experimental Treatment
Non-Treatment Group

270 Total Participants · 2 Treatment Groups

Primary Treatment: AR-15512 Ophthalmic Solution (0.003%) · Has Placebo Group · Phase 3

AR-15512 Ophthalmic Solution (0.003%)
Drug
Experimental Group · 1 Intervention: AR-15512 Ophthalmic Solution · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, 14, 90, 180, 270 & 365

Who is running the clinical trial?

Aerie PharmaceuticalsLead Sponsor
37 Previous Clinical Trials
7,923 Total Patients Enrolled
4 Trials studying Dry Eye Syndromes
1,329 Patients Enrolled for Dry Eye Syndromes
Michelle Senchyna, PhDStudy DirectorAerie Pharma
3 Previous Clinical Trials
1,289 Total Patients Enrolled
3 Trials studying Dry Eye Syndromes
1,289 Patients Enrolled for Dry Eye Syndromes

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a corrected visual acuity equal to or better than logMAR +0.
You have a history of DED within the previous 12 months.
You have a documented Schirmer test with or without topical anesthesia score ≥ 2 and < 10 mm/5 min in at least one eye within 1 year prior to the Baseline visit.
You have a total ocular surface staining score of ≥ 1 and ≤ 12 and no region = 5, based on the Oxford grading scheme at the Baseline visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.