NCT05497479

Study Evaluating Techniques for Measuring Tear Production

A Phase 1 Study Evaluating Techniques for Measuring Tear Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	0.003% AR-15512 to be administered in both eyes	Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512
DRUG	Vehicle to be administered in both eyes	Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
DRUG	0.003% AR-15512 to be administered in both eyes	Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512
DRUG	Vehicle to be administered in both eyes	Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Timeline

• Start date: 2021-12-09
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2022-08-11
• Last updated: 2022-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study