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The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

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Trial Profile

The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Reproxalap (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms TRANQUILITY
  • Sponsors Aldeyra Therapeutics

    • Most Recent Events

    • 27 Nov 2023 According to an Aldeyra Therapeutics media release, the company intends to include in the potential NDA resubmission a draft label describing chronic and acute symptomatic benefit, in addition to acute reduction in ocular redness of reproxalap.
    • 27 Nov 2023 According to an Aldeyra Therapeutics media release, The potential NDA resubmission is anticipated in the first half of 2024.
    • 27 Nov 2023 According to an Aldeyra Therapeutics media release, the company received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for NDA of reproxalap. No safety or manufacturing issues with reproxalap were identified. The NDA did not demonstrate efficacy in treating ocular symptoms associated with dry eyes and at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye should be conducted.

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