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Study Evaluating Techniques for Measuring Tear Production

NCT05497479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michelle S Senchyna, PhD · Aerie Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2021-12-10
Completion
2021-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497479 on ClinicalTrials.gov