Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

X
Trial Profile

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 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 III

Latest Information Update: 04 Dec 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Reproxalap (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms TRANQUILITY-2
  • 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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top