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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03404115

Collaborator

(none)

300

Enrollment

Locations

Arms

6.2

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Reproxalap Ophthalmic Solution (0.25%) Drug: Reproxalap Ophthalmic Solution (0.1%) Drug: Vehicle Ophthalmic Solution	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Actual Study Start Date :

Jan 2, 2018

Actual Primary Completion Date :

Jul 11, 2018

Actual Study Completion Date :

Jul 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%)	Drug: Reproxalap Ophthalmic Solution (0.25%) Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
Experimental: Reproxalap Ophthalmic Solution (0.1%)	Drug: Reproxalap Ophthalmic Solution (0.1%) Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Arm

Intervention/Treatment

Experimental: Reproxalap Ophthalmic Solution (0.25%)

Drug: Reproxalap Ophthalmic Solution (0.25%)

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

Experimental: Reproxalap Ophthalmic Solution (0.1%)

Drug: Reproxalap Ophthalmic Solution (0.1%)

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

Placebo Comparator: Vehicle Ophthalmic Solution

Drug: Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Outcome Measures

Primary Outcome Measures

Assess safety and tolerability of reproxalap formulations using adverse event query. [Safety Assessment Period (Day -14 to Day 85)]
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. [Efficacy assessment period (Day 1 through Day 85)]
Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale. [Efficacy assessment period (Day 1 through Day 85)]
Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on tear film break-up time (TFBUT©). [Efficacy assessment period (Day 1 through Day 85)]
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. [Efficacy assessment period (Day 1 through Day 85)]
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. [Efficacy assessment period (Day 1 through Day 85)]
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. [Efficacy assessment period (Day 1 through Day 85)]
Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Eye Care Group	Waterbury	Connecticut	United States	06708
2	Midwest Cornea Associates	Indianapolis	Indiana	United States	46290
3	Central Maine Eye Care	Lewiston	Maine	United States	04240
4	Andover Eye Associates	Andover	Massachusetts	United States	01810
5	Andover Eye Associates	Raynham	Massachusetts	United States	02767
6	Total Eye Care	Memphis	Tennessee	United States	38119