## Protocol Section
### Identification Module
**NCT ID:** NCT06424444

**Brief Title:** A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

**Official Title:** A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

#### Organization Study ID Info
**ID:** ADX-102-DED-031
#### Organization
**Class:** INDUSTRY
**Full Name:** Aldeyra Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Aldeyra Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

### Conditions Module

**Conditions:**

- Dry Eye Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Reproxalap ophthalmic solution (0.25%)

**Label:** Reproxalap Ophthalmic Solution (0.25%)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Vehicle ophthalmic solution

**Label:** Vehicle Ophthalmic Solution

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Reproxalap Ophthalmic Solution (0.25%)

**Description:** Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks

**Name:** Reproxalap ophthalmic solution (0.25%)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Vehicle Ophthalmic Solution

**Description:** Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks

**Name:** Vehicle ophthalmic solution

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"

**Measure:** Subject-reported ocular discomfort score over Week 1 to Week 6

**Time Frame:** From Day -14 to Day 43

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* at least 18 years of age;
* written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
* history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
* contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* eye drops within 2 hours of Visit 1;
* laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bcavanagh@aldeyra.com

**Name:** Bill Cavanagh

**Phone:** 781-257-3063

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shelby

**Contacts:**

***Contact 1:***

- **Email:** patrickvollmer23@gmail.com

- **Name:** Patrick M. Vollmer, OD

- **Phone:** 828-406-3878

- **Role:** CONTACT

**Country:** United States

**Facility:** Core, Inc.

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 28150

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- 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: HIGH

- As Found: Dry Eye Disease

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10663

- Name: Keratoconjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

- ID: D000005128

- Term: Eye Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: HIGH

- As Found: Start

### Intervention Browse Module - Meshes

- ID: D000019999

- Term: Pharmaceutical Solutions

- ID: D000009883

- Term: Ophthalmic Solutions

### Misc Info Module

- Version Holder: 2024-05-31
