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

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

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 Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.1%); Drug: Vehicle Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • The Eye Care Group
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Midwest Cornea Associates
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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.
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution; Vehicle Ophthalmic Solution 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Safety Assessment Period (Day -14 to Day 85)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 assessment period (Day 1 through Day 85)
Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale.	Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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.	Efficacy assessment period (Day 1 through Day 85)

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): July 11, 2018
• Study Completion (Actual): July 11, 2018

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: reproxalap
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: ADX-102-DED-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No