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Study Evaluating Techniques for Measuring Tear Production (MTP)

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.003% AR-15512 to be administered in both eyes
Vehicle to be administered in both eyes
0.003% AR-15512 to be administered in both eyes
Vehicle to be administered in both eyes
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Eye Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment with Schirmer test with no anesthetic

Treatment with Schirmer test with anesthetic

Arm Description

Both eyes will be treated.

Both eyes will be treated.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2022
Last Updated
August 9, 2022
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05497479
Brief Title
Study Evaluating Techniques for Measuring Tear Production
Acronym
MTP
Official Title
A Phase 1 Study Evaluating Techniques for Measuring Tear Production
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Schirmer test with no anesthetic
Arm Type
Experimental
Arm Description
Both eyes will be treated.
Arm Title
Treatment with Schirmer test with anesthetic
Arm Type
Experimental
Arm Description
Both eyes will be treated.
Intervention Type
Drug
Intervention Name(s)
0.003% AR-15512 to be administered in both eyes
Intervention Description
Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512
Intervention Type
Drug
Intervention Name(s)
Vehicle to be administered in both eyes
Intervention Description
Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
Intervention Type
Drug
Intervention Name(s)
0.003% AR-15512 to be administered in both eyes
Intervention Description
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512
Intervention Type
Drug
Intervention Name(s)
Vehicle to be administered in both eyes
Intervention Description
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle
Primary Outcome Measure Information:
Title
Unanesthetized Schirmer test
Description
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.
Time Frame
Day 1
Title
Unanesthetized Schirmer test
Description
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.
Time Frame
Day 1
Title
Unanesthetized Schirmer test
Description
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.
Time Frame
Day 1
Title
Anesthetized Schirmer test
Description
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.
Time Frame
Day 1
Title
Anesthetized Schirmer test
Description
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.
Time Frame
Day 1
Title
Anesthetized Schirmer test
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle S Senchyna, PhD
Organizational Affiliation
Aerie Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Evaluating Techniques for Measuring Tear Production

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