## Protocol Section
### Identification Module
**NCT ID:** NCT05497479

**Acronym:** MTP

**Brief Title:** Study Evaluating Techniques for Measuring Tear Production

**Official Title:** A Phase 1 Study Evaluating Techniques for Measuring Tear Production

#### Organization Study ID Info
**ID:** 21-110-A
#### Organization
**Class:** INDUSTRY
**Full Name:** Aerie Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2021-12-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-11

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-10

**Type:** ACTUAL

#### Start Date
**Date:** 2021-12-09

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2022-08-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-07-26
**Study First Submit QC Date:** 2022-08-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Aerie Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Dry Eye Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Both eyes will be treated.

**Intervention Names:**

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

- Drug: Vehicle to be administered in both eyes

**Label:** Treatment with Schirmer test with no anesthetic

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Both eyes will be treated.

**Intervention Names:**

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

- Drug: Vehicle to be administered in both eyes

**Label:** Treatment with Schirmer test with anesthetic

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment with Schirmer test with no anesthetic

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

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

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment with Schirmer test with no anesthetic

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

**Name:** Vehicle to be administered in both eyes

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Treatment with Schirmer test with anesthetic

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

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

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Treatment with Schirmer test with anesthetic

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

**Name:** Vehicle to be administered in both eyes

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Unanesthetized Schirmer test

**Time Frame:** Day 1

**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.

**Measure:** Unanesthetized Schirmer test

**Time Frame:** Day 1

**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.

**Measure:** Unanesthetized Schirmer test

**Time Frame:** Day 1

**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.

**Measure:** Anesthetized Schirmer test

**Time Frame:** Day 1

**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.

**Measure:** Anesthetized Schirmer test

**Time Frame:** Day 1

**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.

**Measure:** Anesthetized Schirmer test

**Time Frame:** Day 1

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Newport Beach

**Country:** United States

**Facility:** Eye Research Foundation

**State:** California

**Zip:** 92663

#### Overall Officials

**Official 1:**

**Affiliation:** Aerie Pharmaceuticals

**Name:** Michelle S Senchyna, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye Disease

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000005128

- Term: Eye Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
