ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03404115
Recruitment Status : Active, not recruiting
First Posted : January 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404115


Locations
United States, Indiana
Midwest Cornea Associates
Indianapolis, Indiana, United States, 46290
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.

Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03404115     History of Changes
Other Study ID Numbers: ADX-102-DED-009
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aldeyra Therapeutics, Inc.:
reproxalap

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions