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A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.1%)

Vehicle Ophthalmic Solution

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring reproxalap

Eligibility Criteria

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

Inclusion Criteria:

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Exclusion Criteria:

Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Sites / Locations

The Eye Care Group
Midwest Cornea Associates
Central Maine Eye Care
Andover Eye Associates
Andover Eye Associates
Total Eye Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.1%)

Vehicle Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Assess safety and tolerability of reproxalap formulations using adverse event query.

Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.

Secondary Outcome Measures

Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale.

Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.

Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale.

Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.

Efficacy of reproxalap on tear film break-up time (TFBUT©).

Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.

Efficacy of reproxalap on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.

Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome.

Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.

Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.

Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.

Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.

Full Information

NCT ID

NCT03404115

First Posted

January 12, 2018

Last Updated

July 10, 2019

Sponsor

Aldeyra Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03404115

Brief Title

A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Official Title

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2, 2018 (Actual)

Primary Completion Date

July 11, 2018 (Actual)

Study Completion Date

July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aldeyra Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

6. Conditions and Keywords

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

Dry Eye Syndrome

Keywords

reproxalap

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reproxalap Ophthalmic Solution (0.25%)

Arm Type

Experimental

Arm Title

Reproxalap Ophthalmic Solution (0.1%)

Arm Type

Experimental

Arm Title

Vehicle Ophthalmic Solution

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Reproxalap Ophthalmic Solution (0.25%)

Intervention Description

Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.

Intervention Type

Drug

Intervention Name(s)

Reproxalap Ophthalmic Solution (0.1%)

Intervention Description

Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.

Intervention Type

Drug

Intervention Name(s)

Vehicle Ophthalmic Solution

Intervention Description

Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Primary Outcome Measure Information:

Title

Assess safety and tolerability of reproxalap formulations using adverse event query.

Description

Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.

Time Frame

Safety Assessment Period (Day -14 to Day 85)

Secondary Outcome Measure Information:

Title

Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale.

Description

Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.

Time Frame