Study Evaluating Techniques for Measuring Tear Production

NCT05497479 | Completed Phase 1 FDA Drug

• 1 other identifier: 21-110-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Unanesthetized Schirmer test

  Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.

  Day 1

• Unanesthetized Schirmer test

  Mean change in Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.

  Day 1

• Unanesthetized Schirmer test

  Mean Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.

  Day 1

• Anesthetized Schirmer test

  Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.

  Day 1

• Anesthetized Schirmer test

  Mean change in anesthetized Schirmer score. Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.

  Day 1

• Anesthetized Schirmer test

  Mean anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.

  Day 1

Study Arms (2)

Treatment with Schirmer test with no anesthetic

EXPERIMENTAL

Both eyes will be treated.

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

Treatment with Schirmer test with anesthetic

EXPERIMENTAL

Both eyes will be treated.

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

Interventions

0.003% AR-15512 to be administered in both eyes DRUG

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

Treatment with Schirmer test with no anesthetic

Vehicle to be administered in both eyes DRUG

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

Treatment with Schirmer test with no anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Michelle S Senchyna, PhD

  Aerie Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 11, 2022
• Study Start: December 9, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)