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

January 14, 2025 updated by: Aldeyra Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
Time Frame: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort & 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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 assessment period (Day 1 through Day 85)
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.
Efficacy assessment period (Day 1 through Day 85)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aldeyra Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Dietary Supplements

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