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Study Evaluating Techniques for Measuring Tear Production (MTP)

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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