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The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT03879863
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Brief Summary:
The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Reproxalap Ophthalmic Solution (0.25%) QID Drug: Vehicle Ophthalmic Solution QID Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID Drug: Vehicle Ophthalmic Solution QID to BID Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) QID Drug: Reproxalap Ophthalmic Solution (0.25%) QID
Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks

Placebo Comparator: Vehicle Ophthalmic Solution QID Drug: Vehicle Ophthalmic Solution QID
Vehicle Ophthalmic Solution administered QID for twelve weeks

Experimental: Reproxalap Ophthalmic Solution (0.25%) QID to BID Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID
Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks

Placebo Comparator: Vehicle Ophthalmic Solution QID to BID Drug: Vehicle Ophthalmic Solution QID to BID
Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks




Primary Outcome Measures :
  1. Subject-reported ocular dryness score (0 - 100 VAS) [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)

  2. Fluorescein nasal region score (Ora Calibra® scale) [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)


Secondary Outcome Measures :
  1. Fluorescein staining [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment for this outcome is the Fluorescein staining Ora Calibra®

  2. Unanesthetized Schirmer's Test [ Time Frame: Efficacy assessment period (Week 2 through Week 12) ]
    The method of assessment for this outcome is the Schirmer test strip.



Information from the National Library of Medicine

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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, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
  • Have or 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 ophthalmic cyclosporine 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;
  • Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

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): NCT03879863


Locations
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United States, California
Eye Research Foundation
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03879863     History of Changes
Other Study ID Numbers: ADX-102-DED-012
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions