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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 11, 2018

Interventions

  • Drug: Reproxalap Ophthalmic Solution (0.25%)
    • Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
  • Drug: Reproxalap Ophthalmic Solution (0.1%)
    • Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
  • Drug: Vehicle Ophthalmic Solution
    • Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Arms, Groups and Cohorts

  • Experimental: Reproxalap Ophthalmic Solution (0.25%)
  • Experimental: Reproxalap Ophthalmic Solution (0.1%)
  • Placebo Comparator: Vehicle Ophthalmic Solution

Clinical Trial Outcome Measures

Primary Measures

  • Assess safety and tolerability of reproxalap formulations using adverse event query.
    • Time Frame: Safety Assessment Period (Day -14 to Day 85)
    • Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.

Secondary Measures

  • Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale.
    • Time Frame: 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.
    • Time Frame: 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©).
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: Efficacy assessment period (Day 1 through Day 85)
    • Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aldeyra Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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