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NCT Number: NCT03879863

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 lifitegrast 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

Treatment and study plan

Reproxalap Ophthalmic Solution (0.25%) QID

Drug

Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks

Vehicle Ophthalmic Solution QID

Drug

Vehicle Ophthalmic Solution administered QID for twelve weeks

Reproxalap Ophthalmic Solution (0.25%) QID to BID

Drug

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

Vehicle Ophthalmic Solution QID to BID

Drug

Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

Primary outcomes

  1. Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))

    Time frame: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.

    Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.

  2. Fluorescein Nasal Region Score (0 = None - 4 = Severe)

    Time frame: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.

    Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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