Study Evaluating Techniques for Measuring Tear Production

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2021-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment with Schirmer test with no anesthetic

Both eyes will be treated.

Group Type EXPERIMENTAL

0.003% AR-15512 to be administered in both eyes

Intervention Type DRUG

Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512

Vehicle to be administered in both eyes

Intervention Type DRUG

Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle

Treatment with Schirmer test with anesthetic

Both eyes will be treated.

Group Type EXPERIMENTAL

0.003% AR-15512 to be administered in both eyes

Intervention Type DRUG

Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512

Vehicle to be administered in both eyes

Intervention Type DRUG

Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Interventions

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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

Intervention Type DRUG

Vehicle to be administered in both eyes

Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle

Intervention Type 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

Intervention Type DRUG

Vehicle to be administered in both eyes

Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
* Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
* Within the last year from Visit 1, have documented symptoms of DED
* Corrected Visual Acuity (Snellen) 20/200 or better in both

Exclusion Criteria

* Use of artificial tears within 2 hours prior to Visit 1
* Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
* Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
* Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
* Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No