Study Evaluating Techniques for Measuring Tear Production (MTP)

Aerie Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: Vehicle to be administered in both eyes; Drug: 0.003% AR-15512 to be administered in both eyes

Study type: Interventional

Funder types: Industry

Identifiers

NCT05497479

21-110-A

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Treatment with Schirmer test with no anesthetic

Experimental group

Description:

Both eyes will be treated.

Treatment:

Drug: Vehicle to be administered in both eyes

Drug: 0.003% AR-15512 to be administered in both eyes

Drug: Vehicle to be administered in both eyes

Drug: 0.003% AR-15512 to be administered in both eyes

Treatment with Schirmer test with anesthetic

Experimental group

Description:

Both eyes will be treated.

Treatment:

Drug: Vehicle to be administered in both eyes

Drug: 0.003% AR-15512 to be administered in both eyes

Drug: Vehicle to be administered in both eyes

Drug: 0.003% AR-15512 to be administered in both eyes